Recalling Firm
D. D. Eisenhower Army Med. Ctr. - Blood Bank
Blood Systems, Inc. dba United Blood Services
Community Blood Centers of Florida, Inc.
South Dakota Lions Eye and Tissue Bank, Inc.
LifeSouth Community Blood Centers Inc - Birmingham Region

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
The product was distributed to 79 consignees throughout the USA and Canada.
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Denmark, France, Germany, Israel, Italy, Netherlands, and United Kingdom.
Nationwide; CANADA, BRAZIL, GERMANY, ALGERIA, ESTONIA, SPAIN, FRANCE, GREAT BRITAIN, HONG KONG, ISRAEL, ITALY, JAPAN, POLAND, ROMANIA, SAUDI ARABIA, SWEDEN, SINGAPORE, TUNISIA, TAIWAN, URUGUAY, SOUTH AFRICA.
Worldwide Distribution - USA (nationwide) and Canada
Nationwide distribution: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, KY, LA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, PA, SC, TX, UT, VA, WA & WV. No shipments were made to foreign countries including Canada.
Nationwide distribution: USA state of: Arkansas only
Worldwide distribution: International only-country of: Terumo Dubai, UAE
Worldwide Distribution - USA (nationwide) and the countries of : AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BANGLADESH BELGIUM BOLIVIA BOSNIA AND HERZEGOWINA BRAZIL BRUNEI DARUSSALAM BULGARIA CAMBODIA CANADA CHILE CHINA COLOMBIA COSTA RICA CROATIA (local name: Hrvatska) CYPRUS CZECH REPUBLIC DENMARK ECUADOR EGYPT EL SALVADOR ESTONIA ETHIOPIA FINLAND FRANCE GERMANY GREECE GUADELOUPE HONG KONG ICELAND INDIA INDONESIA IRAQ IRELAND ISRAEL ITALY JAPAN JORDAN KENYA KOREA, REPUBLIC OF KUWAIT LAOS LATVIA LEBANON LIBYAN ARAB JAMAHIRIYA LITHUANIA LUXEMBOURG MACAU MACEDONIA MALAYSIA MALTA MEXICO MOROCCO NAMIBIA NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NIGERIA NORWAY OMAN PAKISTAN PANAMA PAPUA NEW GUINEA PARAGUAY PERU PHILIPPINES POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIAN FEDERATION SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SRI LANKA SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA TANZANIA, UNITED REPUBLIC OF THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM UZBEKISTAN VENEZUELA VIET NAM YEMEN
AZ CA FL IA IL IN MA MI MN MO OH PA TX WI
Products were sold directly to the consumers though our Whole Foods Market Retail stores in the state of Florida.
Worldwide Distribution - USA including AL, AZ, CA, CO, CT, FL, HI, IK, IL IN, IA, KS, LA, MD, MA, MI, MN,MO, NV, NH, NH, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA, WV, and WI,.and internationally to: AUSTRALIA, AZERBAIJIN, BAHRAIN, BELARUS, BULGARIA, CANADA, CHILE, CHINA, CZECH REPUBLIC, EGYPT, FRANCE, GERMANY, INDIA, INDONESIA, IRAQ, IRELAND, ITALY, JAPAN, KUWAIT, LEBANON, LIBYA, MALAYSIA, MEXICO, POLAND, PORTUGAL, ROMANIA, RUSSIA, SADI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, TAIWAN, THAILAND, UNITED ARAB EMIRATES, UNITED KINGDOM, and YEMEN.
Worldwide distribution: USA (nationwide) and countries of: England, United Kingdom and United Arab Emirates.
Alabama, Arkansas, Connecticut, Delaware, DC, Florida, Georgia, Florida, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carlina, South Dakota, Tennessee, Vermont, Virginia, Wisconsin, and West Virginia.
Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Canada, and Lebanon
Nationwide Distribution-including the states of IL, MN, NV, OK, and TX.
Worldwide distribution: USA (nationwide) and countries of: Belgium, Canada, Denmark, France, Germany, Netherlands and UK.
Nationwide Distribution including GA, MI, NY, and PA.
The 4 oz. product was distributed to 25 stores and the. 8 oz. product was distributed to 197 stores. Stores are located in Illinois, Indiana, Kentucky, Michigan, and Ohio. Product was distributed from Meijer's distribution centers located in lansing, Michigan; Newport, Michigan; and Tipp City, Ohio.
Worldwide Distribution -- USA (nationwide) and the countries of Bahrain and Hong Kong.
Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, NK, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY and the countries of Canada, Costa Rica and the Virgin Islands.
Worldwide Distribution-USA (nationwide including the states of CO, NY, OK, PA, UT, VA, and WI, and the countries of Spain and the Netherlands.
The firm distributed to one firm in Indiana.
Nationwide Distribution including DC & MD
Firm distributed to 6 direct consignees located in CA and NY.
FL, IL, KS, MS, NJ, NY, OH, VA & Australia
Worldwide Distribution -- USA (nationwide) Distribution
Distributed to one direct account in Florida who further distributed the entire shipment to one account in Dallas, TX.
Worldwide distribution: USA (nationwide) including state of: Ohio and country of United Kingdom
Nationwide distribution: USA including states of: IN, MI, MS, TN and TX.
US Nationwide Distribution including the states of: GA, IA, KS, NC and TX.
Worldwide distribution: USA (nationwide) and countries of: Australia, Austria, Belgium, Canada, Columbia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Iran, Ireland, Israel, Italy, Japan, Lebanon, Libya, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Saudia Arabia, Singapore, Slovak, Spain, SRI Lanka, Sweden, Turkey, United Arab Emirates, and United Kingdom.

Product Description
ORTHO-ProVue (TM) A modular, microprocessor-controled instrument.
CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps and cardiac chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the System's display screen. The CARTO 3 V1.05 System is also intended to support EP procedures, maintaining CARTO XP System capabilities, in the presence of a high metallic environment and provide a data communication channel to the Stereotaxis Niobe Catheter Guidance System as well as in a regular EP lab. The CARTO 3 V1.05 System includes the CartoMerge capability to import, register and merge CT or MRI structural images with CARTO Maps physiological information and real time catheter navigation, the Fast Anatomical Mapping (FAM) functionality, enabling creation of cardiac maps using'catheters with magnetic proximal and distal location sensors and the CartoSound image integration functionality, that enables integration of intracardiac echo (ICE) visualization to provide 3D combined maps. In addition to the use of specialized navigation catheters, the system is also intended for use with non-navigational electrophysiology catheters.
Life Technologies'': BRAND NAME: ABC SSP UniTray Kit, A Locus SSP UniTray Kit, ABDR SSP UniTray Kit, ABDRDQ SSP UniTray Kit, AllSet+'' Gold SSP HLA-A Locus Low Res Kit, AllSet+'' Gold SSP HLA-ABC Low Res Kit, AllSet+'' Gold SSP HLA-ABDR Low Res Kit, AllSet+'' Gold SSP HLA-ABDRDQ Low Res Kit Invitrogen'' , 9099 North Deerbrook Trail, Brown Deer, Wisconsin 53223 USA.
SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation. The device is intended to be used for tanning of the human skin.
CalDensity Black Label, CalDensity White Label with HA, packaged in white plastic 5, 15, 25, 40, 60 lb pails with plastic liner and white plastic lid.
Red Blood Cells (Apheresis) Leukocytes Reduced
REF 101-05-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 3.2mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 3.2mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
REF 101-45-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 4.5mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
REF 101-45-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 4.5mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
Blood and Blood Products for Reprocessing
South Dakota Lions Eye Bank, Cornea, SD11-079, For single use only, Not considered sterile, Culturing Recommended.
Safety monitor included with System 8000 Base The Sarns'' Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. The safety monitor is indicated to warn when the blood level in the reservoir reaches the operator-set limit, and to stop the arterial and cardioplegia pumps.
Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6 The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
Platelets Pheresis Leukocytes Reduced Irradiated
AquaRoyale Oyster IQF Packed By Dai One Food.Co., LTD. Packed For: Sunny Seafoods, Inc. 11 Sunflower Avenue, Paramus, NJ 07652. USA NET WT.: 20 LBS (40/8oz) ICSSL No. KR-8-SP
Frozen Cooked Oyster: 1) Cooked Oyster 40-90 CT/LB IQF Packed By: Dai One Food.Co., LTD. Country of Origin: Republic of Korea. NET WT.: 40 LBS with 8 LBS Glaze; ICSSL No. KR-8-SP 2) AquaRoyale FROZEN COOKED OYSTER IQF PACKED FOR: SUNNY SEAFOODS INC. 11 SUNFLOWER AVENUE, PARAMUS, NJ 07652 U.S.A. NET WT.: 4 LBS (1/40 LBS) PACKED BY DAI ONE FOOD CO., LTD. ICSSL NO. KR-8-SP.
Half Shell Oyster Imported By: KORYEO INT'L CORP 200 STEWART AVENUE, BROOKLYN, NY 11237; SPEC 72PCS; COUNTRY OF ORIGIN: REPUBLIC OF KOREA; METHOD OF PRODUCTION: FARM RAISED; ICSSL No. KR-8-SP
BLN Fescue Forage Blend CTC NB-0451, Type B Medicated Feed For Beef Cattle, containing 1.4 g/lb. chlortetracycline, packaged in 50-lb. bags. The tag is labeled Manufactured by: Nutra Blend, LLC, Neosho, MO. The bag lists the firm name as Bass Livestock Nutrition, LLC, Rogersville, MO.
Garden-Fresh Anti Pasto Salad Base, Net Wt. 4 lbs., UPC 0 11596 65634 2
Garden-Fresh Pickled Beet And Onion Salad, Net Wt. 5 lbs., UPC 0 11596 52051 3
Acme Creamed Cabbage, Net Wt. 16 oz., UPC 0 11596 14025 1
Creamy Cole Slaw packaged under the following brand, salad name, container size, and UPC number: 1) Garden-Fresh Creamy Cole Slaw Kit , 6 lbs., 0 11596 63039 7; 2) Spartan Creamy Shredded Cole Slaw, 16 oz., 0 11213 90322 4, & 3 lbs., 0 11213 90327 9; 3) Garden-Fresh Creamy Shredded Cole Slaw, 16 oz., 0 11596 1402 3, 2 lb., 011596 24203 3, 5 lb., 0 11596 93014 5, 8 lb., 0 11596 53005 5; 4) Weis Creamy Cole Slaw, 16 oz., 0 41497 05837 2 , 3 lb., 0 41497 059906 5, 5 lb., 0 1596 53101 4
Rogges Sour Cream Cuke Salad, 5 lbs., UPC 0 11596 52057 5
Archer Farms Layered Taco Dip Kits - Taco Dip, kit, 0 11 11596 36300 4
Chef's Kitchen Deluxe Egg Salad, 5 lbs., 0 11596 52044 5
German Potato Salads packaged under the following brand, dip name, container size, and UPC number: 1. Copperwood Kitchens German Potato Salad, 5 lbs., 8 11839 01033 3; 2. Garden-Fresh German Potato Salad, 16 oz., 0 11596 14017 9 ,3 lbs., 0 11596 34319 8 , 5 lbs., 0 11596 91020 8 3. Grandpa's German Potato Salad, 5 lbs., 0 11596 91023 9
DF Homemade macaroni Salad, 5 lbs., 0 70163 89080 0 ;
Garden-Fresh Potato Pancakes 4 lbs. 0 11596 40425 5
Weis Spiral Pasta Salad, 5 lbs, 0 11596 52107 7
Garden-Fresh Bacon Mac & Cheddar Salad Kit 5.75 lbs. 0 11596 62209 5
Garden-Fresh Tomato Mozzarella Salad Kit 4 lbs. 0 11596 55163 0
Finest Traditions Smoked Imitation Salmon, 12 oz., 7 33147 00127 1; 8 lbs., 10 733147 10120 6
Finest Traditions Spinach Dip, 8 oz., 7 33147 10538 2
Tuna Salad packaged under the following brand name, container size, UPC code: Finest Traditions Tuna Salad Spread 12 oz. 7 33147 10487 3 Finest Traditions Tuna Salad Spread 4 lbs. 10 733147 10186 2 Garden-Fresh Premium Tuna Salad 5 lbs. 0 11596 55101 2 Market Pantry Tuna Salad 12 oz. 0 85239 24108 0 Weis Tuna Salad 8 oz. 0 41497 05345 2
Finest Traditions Garden Vegetable Spaghetti 8 lbs., 10 733147 10196 1
Finest Traditions Wild Rice Salad Base, 8 lbs., 10 733147 10183 7
Garden-Fresh Family Style Creamy Tuna Salad 5 lbs. 0 11596 55108 1
Garden-Fresh Fresh Mango Salsa 5 lbs. 0 11596 59025 3
Garden-Fresh Black Bean Salsa, 15 oz., 0 11596 06118 4 Garden-Fresh Black Bean Salsa, 5 lbs., 0 11596 52587 7
Finest Traditions Fat Free Black Bean Salsa, 8 lb., 10 733147 10181 7
Garden-Fresh Baked Potato Salad Kit, 5 lb., 0 11596 61071 9
Knowlan's Club Salad Base, 8 lb.,10 733147 10201 5
Copperwood Kitchens Greek Style Pasta Salad 5 lbs. 8 11839 01032 6 Garden-Fresh Greek Style Pasta Salad 5 lbs. 0 11596 52035 3
Bow Tie Pastas: 1) Copperwood Kitchens Venetian Bow Tie Pasta, 5 lbs., 8 11839 01031 9; 2) Garden-Fresh Venetian Bowtie Pasta, 5 lbs., 0 11596 520278
Finest Traditions Pea & Cheese Pasta Salad, 8 lb., 10 733147 10146 6
Finest Traditions Rigatoni Pasta Salad, 8 lb., 10 733147 10148 0
Garden-Fresh California Pasta Salad, 5 lbs, 0 11596 82068 2 Garden-Fresh California Pasta Salad, 5 lbs., 0 11596 52115 2
Italian Pasta Salad: 1) Garden-Fresh Italian Pasta Salad, 8 lbs., 0 11596 92012 4; 2) Market Pantry Italian Pasta Salad 14 oz., 0 85239 20119 0
Garden-Fresh Ranch Pasta Salad, 5 lb., 0 11596 52202 9
Garden-Fresh Seafood Pasta Salad, 5 lb., 0 11596 55007 7
Garden-Fresh Southwestern Pasta Salad, 5 lb., 0 11596 52046 9
Taco Pasta Salad: 1) Garden-Fresh Taco Pasta Salad, 5 lbs., 0 11596 52076 6; 2) Garden-Fresh Taco Pasta Salad, 5 lbs., 0 11596 52065 0
Our Own Fettuccine Pasta Salad, lb., 0 11596 52150
DF Special Recipe Macaroni Salad, 16 oz., 0 70163 98110 2
Finest Traditions Creamy Cheddar Macaroni , 8 lbs., 10 733147 10156 5
Garden-Fresh Family Style Macaroni Salad 2060 5 lbs 0 11596 52060 5
Copperwood Kitchens Deviled Egg Potato Salad, 00295, 8/15/2012-8/20/2012
Garden-Fresh Deviled Egg Salad, 5 lbs, 0 11596 521220
Egg Salad Spreads: 1) Garden-Fresh Egg Salad Spread, 5 lbs., 0 11596 52053 7; 2) Finest Traditions Egg Salad Spread, 12 oz., 7 33147 10491 0 & 4 lbs., 10 733147 10189
Roundy's Old Fashioned Cream Dill Dip, 12 oz., 0 11150 52603 6
Garden-Fresh Sweet and Sour cucumber, 5 lbs., UPC 0 11596 52014 8;
Grandpas Sour Cream Cucumbers Salad, 5 lbs., UPC 0 11596 52080 3;
Garden-Fresh Cranberry Walnut Red Cabbage Slaw Base, 8 lbs., 0 11596 83028 5;
Garden-Fresh Creamy Cole Slaw Dressing , 2 lbs., 0 11596 43200 7
Dixie Cole Slaws:1) Garden-Fresh Dixie Cole Slaw, 5 lbs., 0 11596 93007 7 ; 2) DF Special Recipe Dixie Cole Slaw, 16 oz. 0 70163 98115 7
Garden-Fresh Amish Country Cole Slaw, 5 lbs., 0 11596 53010 9;
Finest Traditions Homemade-Style Cole Slaw, 8 lbs., 10 733147 10170 1; Finest Traditions Homemade Style Cole Slaw, 16 oz., 7 33147 00025 0;
Finest Traditions XTRA Creamy Cole Slaw, 8 lbs., 10 733147 10017 9;
Finest Traditions Creamy Country Cole Slaw, 8 lbs., 10 733147 10172 5;
Garden-Fresh Black Bean Couscous, 5 lbs., 0 11596 55620 8
Garden-Fresh Kidney Bean Salad , 5 lbs., 0 11596 52016
Archer Farms Four Bean Salad, 14 oz., 0 85239 24207 0
Finest Traditions Fat Free Bean Salad, 8 lbs., 10 733147 10180 0
Acme Classic Potato Salad 16 oz. 0 11596 14030 5
Potato Salad with Egg: 1) Acme Homestyle Egg Potato Salad, 16 oz. 0 11596 14005 3; 2) Weis Potato w/ Egg Salad, 16 oz., 0 41497 05841 9, 3 lb., 0 41497 05902 7, 5 lb., 0 11596 51101 6
Homestyle Potato Salads: 1) Acme Homestyle Potato Salad, 2 lbs. 0 11596 34209 2 ; 2) Finest Traditions Homestyle Potato Salad, 16 oz., 7 33147 00019 9, 3 lb., 7 33147 00031 1 , 8 lb., 10 733147 10134 3
Mustard Potato Salads: 1) Copperwood Premium Mustard Potato Salad, 2 lbs., 8 11839 01001 2, 5 lbs.; 2) Dairy Fresh Mustard Potato Salad, 0 070163 89090 9, 5 lbs.; 3) Garden Fresh Mustard Potato Salad, l lb., 0 11596 14010 0, 2 lb. 0 11596 24215 6; 4) Market Pantry Mustard Potato Salad, 16 oz., 0 85239 24104 2, 3 lb., 0 85239 24100 4; 5) Spartan Mustard Potato Salad, 1 lb., 0 11213 90319 4, 3 lb., 0 11213 90324; 6) Spoon River Mustard Potato Salad, 3 lb., 0 11596 24207 8; 7) Rogges Mustard American Potato Salad, 5 lb., 0 11596 51053 3
Steakhouse Potato Salads: 1) Copperwood Steakhouse Potato Salad, 5 lbs., 8 11839 01001 7, 5 lb.; 2) Grandpas Steakhouse Potato Salad, 5 lb., 0 11596 55604 8; 3) Finest Traditions Steak House Potato Salad, 8 lb., 10 733147 10773 4
Dairy Fresh Special Recipe Potato Salad, 5 lbs., 0 70163 40659 7, 5 lbs.
Premium Potato Salads: 1) Copperwood Premium Potato Salad, 2 lb., 8 11839 01000 5, 5 lb., 8 11839 01016 6; 2) Our Own Premium Potato Salad, 5 lb., 0 11596 91045 1
Dairy Fresh Baked Potato Salad, 5 lb., 0 70163 40659
Dairy Fresh Special Recipe Mustard Potato Salad, 16 oz.., 0 70163 98105 8
Dairy Fresh Special Recipe Potato Salad, 16 oz.., 0 70163 98135 5
Finest Traditions Blue Cheese Potato Salad, 8 lb., 10 733147 10137 4
Finest Traditions Roasted Garlic Potato Salad, 8 lb., 10 7 33147 10159 6
American Potato Salads: 1) Garden-Fresh American Potato Salad, 1 lb., 0 11596 14015 5, 2 lb., 0 11596 24200 2; 2) Market Pantry American Potato Salad, l lb., 0 85293 24107 3, 3 lb., 0 85239 24102 8; 3) Spartan American Potato Salad, 3 lb., 0 11213 90325 5
Amish Potato Salads: 1) Garden-Fresh Amish Country Potato Salad, 5 lb., 0 11596 51005 7; 2) Weis Amish Potato Salad, 16 oz., 0 41497 05845 7, 3 lb., 0 41497 05901 0, 5 lb., 0 11596 51103 0
Garden-Fresh Country Style Potato Salad, 5 lb., 0 11596 51075 0
Garden-Fresh Family Style Potato Salad, 5 lb., 0 11596 51061 3
Garden-Fresh Gourmet Dill Potato Salad, 5 lb., 0 11596 55137 1
Garden-Fresh Large Diced American Potato Salad, 5 lb., 0 11596 91018 5
Red Potato Salads: 1) Garden-Fresh Red Potato Salad, 2 lb., 0 11596 24205 7; 2) Weis Red Potato Salad, 16 oz., 0 41497 05848, 5 lb., 0 11596 51105 4
Garden-Fresh Reduced Fat American Potato Salad, 5 lb., 0 11596 51201 2
Reduced Fat Mustard Potato Salads: 1) Garden Fresh Reduced Fat Mustard Potato Salad, 5 lb., 0 11596 51202 0; 2) Market Pantry Reduced Fat Mustard Potato Salad, 16 oz., 0 85239 20016 2
Deviled Egg Potato Salads: ) Grandpas Deviled Egg Potato Salad, 1 lb., 0 11596 14012 4; 5 lb., 0 11596 51065 1; 3.5 oz., 0 11596 08005 5; 2) Copperwood Kitchens Deviled Egg Potato Salad, 00295
Grandpas Red Skin Potato Salad, 5 lb., 0 11596 51080 4
Spoon River Potato Salad, 5 lb., 0 11596 51032 3
Marsh's Signature Potato Salad, 5 lb., 0 11596 51085 9
Rogges White Potato Salad, 5 lb., 0 11596 51052 1
Acme Homestyle Cole Slaw, 16 oz., 0 11596 14304 3
Garden-Fresh Family Style Cole Slaw, 5 lb., 0 11596 53060 4
The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. BABY SHRIMP SALAD
Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. BEET & GOAT CHEESE SALAD WITH RASPBERRY VINAIGRETTE
Beet Dressing sold at the chef's case, self service bar, or sold packaged. Packaged product is labeled as listed below: ''WHOLE FOODS MARKET***BEET DRESSING***RED BEETS, HONEY, GARLIC, ONIONS, CANOLA MAYONNAISE (CANOLA OIL, EGGS, HONEY, VINEGAR, SALT, SPICES, LEMON JUICE), APPLE CIDER VINEGAR (APPLE CIDER VINEGAR, WATER) CONTAINS: EGGS***''
Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. CHUNKY RANCH VEGETABLE SALAD NO OIL ADDED
Cranberry Tuna Salad Roll sold at the chef's case, self service bar, or packaged. Packaged product is labeled as listed below: ''WHOLE FOODS MARKET***CRANBERRY TUNA SALAD ROLL 2 FOR 5***BREAD (UNBLEACHED UNBROMATED WHEAT OR WHOLE WHEAT FLOUR, WATER, FLORIDA CRYSTALS SUGAR, PALM OIL, EGGS, NON FAT DRY MILK, ASCORBIC ACID, SALT, YEAST, CULTURED WHEAT FLOUR, SOY LECITHIN & NATURAL ENZYMES), TUNA (TUNA, WATER, VEGETABLE BROTH (CARROTS & PEAS), SALT), ONIONS, SUN-DRIED CRANBERRIES (CRANBERRIES, EVAPORATED CANE SUGAR), CANOLA MAYONNAISE (CANOLA OIL, EGGS, FILTERED WATER, HONEY, VINEGAR, SEA SALT, DRY MUSTARD, LEMON JUICE), LEMONS, TOMATO, LETTUCE CONTAINS: WHEAT, EGGS, MILK, SOY, FISH***''
Gills Onions were used in this product. The Thousand Island Potato Salad is sold at the chef's case, self serve counter, or packaged.It is also sold as ''Family Sized Savings Thousand Island Potato Salad''. Packaged product is labeled as listed below: ''***WHOLE FOODS MARKET***THOUSAND ISLAND POTATO SALAD***POTATOES, CAGE-FREE HARD COOKED EGGS (EGGS, WATER, CITRIC ACID), THOUSAND ISLAND DRESSING....***''
Miso Dressing sold at the chef's case, self service bar, or sold packaged. Packaged product is labeled as listed below: ''WHOLE FOODS MARKET***MISODRESSING***WHITE MISO (WATER, RICE, WHOLE SOYBEAN, SEA SALT, KOJI STARTER), TOFU (FILTERED WATER, (NON-GMO) SOYBEANS, NATURAL COAGULANTS (CALCIUM CHLORIDE (NIGARI), CALCIUM SULFATE), EXTRA VIRGIN OLIVE OIL, WATER, APPLE CIDER VINEGAR (APPLE CIDER VINEGAR, WATER), ONIONS, TAMARI (WATER, SOYBEANS, SALT, ALCOHOL (TO PRESERVE FRESHNESS)), PARSLEY CONTAINS: SOY***''
Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. MISO KISSED CUKES
New York City Corned Beef on Rye sold at the chef's case, or packaged. Packaged product is labeled as listed below: ''WHOLE FOODS MARKET***FANCY REUBEN SANDWICH WITH PASTRAMI OR CORNED BEEF***PASTRAMI OR CORNED BEEF (BEEF, WATER, SEA SALT, SUGAR, BEET POWDER, GARLIC POWDER, SPICES, GARLIC, BAY LEAF, MUSTARD SEED, ALLSPICE) HONEY MUSTARD COLESLAW ( GREEN & RED CABBAGE, CARROTS), HONEY MUSTARD DRESSING ( DIJON MUSTARD (DISTILLED VINEGAR, WATER, MUSTARD SEED, SALT, WHITE WINE, CITRIC ACID, TARTARIC ACID, SPICES, TURMERIC), WHOLEGRAIN MUSTARD ( WATER, GRAIN VINEGAR, MUSTARD SEED, SALT, SPICES), LEMON JUICE, CANOLA MAYONNAISE ( CANOLA OIL, EGGS, HONEY, VINEGAR, SALT, SPICES, LEMON JUICE), HONEY), OR CLASSIC COLESLAW ( GREEN & RED CABBAGE, CARROTS, CANOLA MAYONNAISE, HORSERADISH ( HORSERADISH, WATER, VINEGAR, SALT, NATURAL FLAVORINGS), SUGAR, FENNEL, LEMON PEPPER, CELERY SEED, APPLE CIDER VINEGAR (APPLE CIDER VINEGAR, WATER), SWISS CHEESE ( PART SKIM MILK, CHEESE CULTURE, SALT, ENZYMES), BREAD CIABATTA (ENRICHED WHEAT FLOUR ( WHEAT FLOUR, MALTED BARLEY FLOUR, NIACIN, REDUCED IRON, THIAMIN MONONITRATE, RIBOFLAVIN, FOLIC ACID), WATER, CANOLA OIL, EXTRA VIRGIN OLIVE OIL, RYE SOURDOUGH FLAVOR, SALT, YEAST). CONTAINS: MILK, EGGS, SOY, WHEAT.***''
Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. PASTA WITH LONG BEANS & ARAME IN CREAMY BEET VINAIGRETTE
Ranch Dressing No Oil Added sold at the chef's case, self service bar, or packaged. Packaged product is labeled as listed below: ''WHOLE FOODS MARKET***RANCH DRESSING NO OIL ADDED***TOFU ( WATER, SOYBEANS, ISOLATED SOY PROTEIN, GLUCONOLACTONE & CALCIUM CHLORIDE), OAT MILK, LEMON JUICE, ONION, WHITE VINEGAR, DIJON MUSTARD ( DISTILLED VINEGAR, WATER, MUSTARD SEED, SALT, WHITE WINE, CITRIC ACID, TARTARIC ACID, SPICES, TURMERIC), NUTRITIONAL YEAST, BASIL, GARLIC, CILANTRO, GREEN ONION, DILL, PARSLEY, PEPPER, CRUSHED RED PEPPER. CONTAINS : SOY***''
Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. RANCH ICEBERG SALAD WEDGE NO OIL ADDED
Russian Coleslaw is sold at the chef's case, self serve counter, or packaged. Packaged product is labeled as listed below: ''***WHOLE FOODS MARKET***RUSSIAN COLESLAW***CABBAGE, CARROTS, THOUSAND DRESSING ( CANOLA MAYONNAISE ( CANOLA OIL, EGGS, FILTERED WATER, HONEY, VINEGAR, SEA SALT, DRY MUSTARD, LEMON JUICE), SWEET PICKLE RELISH ( CUCUMBERS, CRYSTALLIZED CANE JUICE, WATER, DISTILLED VINEGAR, SALT, DEHYDRATED PEPPERS, CALCIUM CHLORIDE, XANTHAN GUM, NATURAL SPICE FLAVORS, GUM ARABIC), SWEET THAI CHILI SAUCE ( SUGAR, WATER, CHILI, VINEGAR, GARLIC, SALT, GUAR GUM, CITRIC ACID), ONION, RED HOT SAUCE ( AGED CAYENNE PEPPERS, VINEGAR, WATER, SALT, GARLIC POWDER), LIQUID AMINOS ( FORMULATED SOY PROTEIN, WATER), PAPRIKA, KETCHUP ( TOMATO PUREE, EVAPORATED CANE JUICE, SUGAR, WHITE VINEGAR, SALT, ONION POWDER & SPICES). CONTAINS: EGG, SOY***''
Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. RUSSIAN SALAD
Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. SEASONAL SUCCOTASH
The Shrimp Salad Sandwich is sold at the chef's case, self serve counter, or packaged. Packaged product is labeled as listed below: ''***WHOLE FOODS MARKET***SHRIMP SALAD SANDWICH***SHRIMP, CANOLA MAYONNAISE ( CANOLA OIL, EGGS, FILTERED WATER, HONEY, VINEGAR, SEA SALT, DRY MUSTARD, LEMON JUICE), CELERY, ONIONS, CARROTS, PARSLEY, KOSHER SALT, PEPPER, SPINACH WRAP ( UNBLEACHED UNBROMATED ENRICHED WHEAT FLOUR ( WHEAT FLOUR, NIACIN (VITAMIN B3), REDUCED IRON, THIAMINE MONONITRATE (VITAMIN B1), RIBOFLAVIN (VITAMIN B2), FOLIC ACID ( VITAMIN B 9), MALTED BARLEY FLOUR), WATER, SUNFLOWER OIL, CONTAINS: 2% OR LESS OF: CULTURED WHEAT FLOUR ADDED WITH VINEGAR, SALT, LECITHIN, DRIED SPINACH POWDER, YEAST, GUAR GUM, LEAVENINGS ( SODIUM ACID PYROPHOSPHATE, SODIUM BICARBONATE, CORN STARCH, MONOCALCIUM PHOSPHATE), CITRIC ACID), GREENLEAF LETTUCE, TOMATO. CONTAINS: EGGS, SHELLFISH, WHEAT.***''
Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. SHRIMP WITH SNOW PEAS
Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. SOY & THE SEA
Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. TEMPEH SALAD
The Thousand Island Chicken Salad Roll is sold at the chef's case, self serve counter, or packaged. Packaged product is labeled as listed below: ''***WHOLE FOODS MARKET***1000 ISLAND CHICKEN SALAD ROLL 2 FOR 5***BREAD ( UNBLEACHED UNBROMATED WHEAT OR WHOLE WHEAT FLOUR, WATER, FLORIDA CRYSTALS SUGAR, PALM OIL, EGGS, NON FAT DRY MILK, ASCORBIC ACID, SALT, YEAST, CULTURED WHEAT FLOUR, SOY LECITHIN & NATURAL ENZYMES), CHICKEN ( CHICKEN, WATER, RICE STARCH, SALT), OR TURKEY, CAGE-FREE EGGS (EGGS, WATER, CITRIC ACID), CANOLA OIL, EGGS, FILTERED WATER, HONEY, VINEGAR, SEA SALT, DRY MUSTARD, LEMON JUICE, CUCUMBERS, CRYSTALIZED CANE JUICE, WATER, DISTILLED VINEGAR, SALT, DEHYDRATED PEPPERS, CALCIUM CHLORIDE, XANTHAN GUM, NATURAL SPICE FLAVORS, GUM ARABIC, CALCIUM CHLORIDE, DEHYDRATED BELL PEPPERS, SPICES (CELERY SEED), NATURAL FLAVORS ( CASSIA, CLOVE), CITRIC ACID, ONION, AGED CAYENNE RED PEPPERS, GARLIC POWDER, LIQUID AMINOS ( FORMULATED SOY PROTEIN, WATER), PAPRIKA, KETCHUP ( TOMATO PUREE, EVAPORATED CANE JUICE, SUGAR, WHITE VINEGAR, SALT, ONION POWDER & SPICES), CAPERS ( CAPERS, VINEGAR SALT), GARLIC, EXTRA VIRGIN OLIVE OIL, DILL, CABBAGE, CARROTS, SUGAR, CHILI, SALT, GUAR GUM, CITRIC ACID), AGED CAYENNE RED PEPPERS, PAPRIKA CONTAINS: WHEAT, EGGS, MILK, SOY.***''
Gills Onions were used in this product. The Thousand Island Chicken Salad Sandwich is sold at the chef's case, self serve counter, or packaged. Packaged product is labeled as listed below: ''***WHOLE FOODS MARKET***THOUSAND ISLAND CHICKEN SALAD SANDWICH***CHICKEN ( CHICKEN, SEASONING ( SALT, GRANULATED ONIONS & GARLIC, WHITE PEPPER, BLACK PEPPER), THYME), OR TURKEY, CAGE-FREE EGGS (EGGS, WATER, CITRIC ACID), CABBAGE, CARROTS, THOUSAND ISLAND DRESSING ( CANOLA MAYONNAISE ( CANOLA OIL, EGGS, FILTERED WATER, HONEY, VINEGAR, SEA SALT, DRY MUSTARD, LEMON JUICE), SWEET PICKLE RELISH ( CUCUMBERS, CRYSTALLIZED CANE JUICE, WATER, DISTILLED VINEGAR, SALT, DEHYDRATED PEPPERS, CALCIUM CHLORIDE, XANTHAN GUM, NATURAL SPICE FLAVORS, GUM ARABIC), SWEET THAI CHILI SAUCE ( CUCUMBERS, SUGAR, VINEGAR, SEA SALT, XANTHAN GUM, CALCIUM CHLORIDE, DEHYDRATED BELL PEPPERS, SPICES ( CELERY SEED), NATURAL FLAVORS ( CASSIA, CLOVE), CITRIC ACID), ONION, RED HOT SAUCE ( AGED CAYENNE RED PEPPERS, VINEGAR, WATER, SALT, GARLIC POWDER), ....***''
Conch Salad is labeled as listed below: ''***SALAD CONCH***INGREDIENTS: GROUND CONCH, MOJO (GARLIC, ONION, GRAPEFRUIT JUICE (100% SQUEEZE D), OANGE JUICE (100% SQUEEZED) , LIME JUICE (100% PASTEURIZED ), ONION, EXTRA VIRGIN OLIVE OIL, CUMIN), BLACKENING SEASONING (SALT, SPICES, PAPRIKA, GARLIC, ONION POWDER ( CALCIUM STERATE ), SUGAR, CHILI POWDER ( CHILI PEPPER, SPICES, SALT, SILICON DIOXIDE, SOYBEAN OIL) , SUGAR, 100% PASTEURIZED LIME JUICE, FLORIDA BAY SEASONING ( SALT, SPICES, PAPRIKA ), SALT, TOMATO JUICE ( TOMATO CONCENTRATE (WATER, TOMATO PASTE ), SALT, VITAMIN C ( ASCORBIC ACID ), CUCUMBER, TOMATO, ONION, GREEN PEPPER, BLACK PEPPER, PARSLEY. CONTAINS: SHELLFISH, SOY.*** SELL BY: 08/08/12***NET WT 0.95 LB***550 BOWIE ST. AUSTIN, TX 78703***''
Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. THOUSAND ISLAND SHRIMP SALAD
Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. Thousand Island Surimi
Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. Thousand Island Surimi Crab Salad Roll
Gills Onions were used in this product. The Thousand Island Surimi Salad is sold at the chef's case, self serve counter, or packaged. Packaged product is labeled as listed below: ''***WHOLE FOODS MARKET***THOUSAND ISLAND SURIMI SALAD***SURIMI ( FISH, PROTEIN ( POLLOCK AND/OR PACIFIC WHITING), WATER, SUGAR, WHEAT STARCH, EGG WHITE, POTATO STARCH....***''
Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. THREE BEAN SALAD
Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. TOFU JAPONAISE
Gills Onions were used in this product. The Tuna With Cranberries Salad Sandwich is sold at the chef's case, self serve counter, or packaged. Packaged product is labeled as listed below: ''***WHOLE FOODS MARKET***TUNA SALAD WITH CRANBERRIES (TUNA ( TUNA, WATER, VEGETABLE BROTH (CARROTS & PEAS), SALT), ONIONS....***''
Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. Tuna with Sun-Dried Cranberries
Gills Onions were used in this product. The Tuna With Sun-Dried Cranberries & Lemon is sold at the chef's case, self serve counter, or packaged. Packaged product is labeled as listed below: ''***WHOLE FOODS MARKET***TUNA WITH SUN-DRIED CRANBERRIES AND LEMON*** TUNA ( TUNA, WATER, VEGETABLE BROTH (CARROTS & PEAS), SALT), ONIONS....***''
GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications. K061163: For Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ, Innova 2100IQ devices with Innova IVUS option: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications. Innova IVUS Option: The Innova IVUS software option simplifies the clinical workflow associated with the use of Volcano IVUS products by: (1) automatically synchronizing the patient demographic information (patient name, date of birth, DICOM attributes etc.) from Innova system with an IVUS imaging system, (2) providing a remote access to commonly used IVUS functions from the Innova table side user interface, (3) displaying the IVUS images on the multi-monitor display of the Innova cathlab system. K091658: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fl
Sunquest Laboratory Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is intended for use only by professionals who have received extensive training in the use of the software. Sunquest Laboratory is controlled via userdefined security levels, which allow the laboratories to manage data security and integrity. The system is marketed as an automated solution for managing laboratory processes, including: '' Patient registration '' Order entry and order modification '' Specimen collection, verification, suitability, and distribution '' Quality assurance checking '' Workload recording '' Billing charge capture '' Standards and controls recording '' Test order result inquiry and reporting Organism susceptibility and epidemiology records '' Microbiology culture direct examination and observation recording '' Outreach clients, specimens, and results '' Client-specific reporting capabilities '' Inbound client service request tracking '' Historical data Clients that use the Sunquest Blood Bank system should refer to the intended use statement found in the Blood Bank System Overview Users Guide.
Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use. Used to catheterize patients. The finished trays are sold in Tyvek breather bags.
Crown Program BK Fresh Apple Slices, 2 oz On or before August 13; no upc code
Hannaford Apples & Caramel Snack Pack Net Wt. 4 oz (113g) Distributed By: Hannaford Bros. Co., Scarborough, ME 04074 1-800-213-9040. www.hannaford.com On or before August 18 UPC 4126817191
Hannaford Apple, Granola, & Yogurt Snack Pac, Net Wt. 4.3 oz (122g), Distributed by Hannaford Bros. Co., Scarborough, ME 04074 10-800-213-9040 www.hannaford.com. On or before August 18 UPC 4126817195
McDonalds M Apple Slices Net Wt 1.2 oz (34g) On or before August 19; no upc code
McDonalds M Diced Apples Net Wt. 0.02 oz (26g) On or before August 19; no upc code
McDonalds M fruit & walnut snack with vanilla lowfat yogurt Net Wt 5.75 OZ (163g) On or before August 20; no upc code
Ready Pac Bistro Apple Bleu Pecan Salad Net Wt. 4.75 OZ (135g) Dist. by Ready Pac Foods, Inc., Irwindale, CA 91706 USA 1-800-800-7822 www.readypac.com On or before August 12; UPC 7774529497
Ready Pac fruit frenzy Net Wt. 32 OZ (2 LB) 907 g Distributed by Ready Pac Foods, Inc. Irwindale, CA 91706 USA 1-800-800-782 www.readypac.com On or before August 18; UPC 7774523086
Ready Pac fruit tray bien Net Wt. 32 OZ (2 LB) 907 g Distributed By Ready Pac Foods, Inc. Irwindale, CA 91706 USA 1-800-800-7822 www.readypac.com On or before August 18; UPC 7774521606
Ready Pac Ready Snax Apples & Cheese with Caramel Dip Snack Pac Net Wt. 4 OZ (113g) Distributed By Ready Pac Foods, Inc. Irwindale, CA 91706 USA 1-800-800-7822 readypac.com On or before August 18; UPC 7774523896
Ready Pac Ready Snax Apples, Celery, Raisins with Peanut Butter Snack Pac Net Wt 4 oz (113g) Distributed By Ready Pac Foods, Inc. Irwindale, CA 91706 USA 1-800-800-7822 www.readypac.com On or before August 18; UPC 7774523897
Ready Pac Ready Snax Apples, Granola, & Yogurt Snack Pac Net Wt 4.3 OZ. Distributed By Ready Pac Foods, Inc. Irwindale, CA 91706 USA 1-800-800-7822 www.readypac.com On or before August 18; UPC 7774523089
Ready Pac super fruit blend Net Wt 6 oz (170g) Distributed By Ready Pac Foods Inc., Irwindale, CA 91706 USA 1-800-800-7822 www.readypac.com On or before August 17; UPC 7774523076
Ready Pac super fruit medley Net Wt 10.5 OZ (298g) Dist. by Ready Pac Foods, Inc., Irwindale, CA 91706 USA 1-800-800-7822 www.readypac.com On or before August 16; UPC 7774523746
Ready Pac Sweet Sunshine Platter Net Wt 37 OZ )2 LB 5 OZ) 1.05 Kg Dist. by Ready Pac Foods, Inc., Irwindale, CA 91706 USA 1-800-800-7822 www.readypac.com On or before August 16; UPC 7774524204
Safeway farms Complete Apple, Blue Cheese & Pecan Total Net Wt. 8.75 OZ (248g) Salad & Toppings 6.75 OZ (191g) Dressing 2 OZ (!.83 FL OZ) 54 mL Distributed by Safeway Inc. PO Box 90 Pleasonton, CA 94506-0009 1-800-SAFEWAY/www.safeway.com On or before August 18; UPC 2113033680
Wawa apple caramel dipper Net Wt 6.7 OZ (191g) Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 16; UPC 261900394
Wawa apple peanut butter dipper Net Wt. 6.5 OZ (183g) Distributed by: Wawa, Inc Wawa, PA 19063 wawa.com On or before August 15; UPC 261900268
Wawa apple slices Net Wt 3.5 OZ (99g) Distributed by: Wawa Inc. Wawa, PA 19063 wawa.com On or before August 16; UPC 261902232
Wawa baby carrots Net Wt 3 oz (85g) Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 16; UPC 2619102517
Wawa Chicken salad Snack Net Wt. 6.7 oz Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 12; UPC 261902760
21) Wawa Chicken salad sandwich Net Wt. 7.8 OZ (221g) Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 10; UPC 261905670
) Wawa fruit & cheese Net Wt 6 OZ Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 11; UPC 261902567
Wawa protein power pack Net Wt 7.8 OZ Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 11; UPC 261902565
Wawa red grapes Net Wt 3 OZ (85g) Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 13; UPC 2619102518
Wawa turkey & cheese sandwich Net Wt 7.7 OZ (219g) Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 10; UPC 261905622
Wegmans Apples, Celery, Raisins, & Peanut Butter Net Wt 4 oz. (113g) Distributed by: Wegmans Food Markets, Inc. Rochester, NY 14603 On or before August 18; UPC 7789026744
Wegmans Apples, Cheese & Caramel Dip, 4 OZ (113g) Distributed by: Wegmans Foods Markets, Inc. Rochester, NY 14603 On or before August 15; UPC 7789026743
Wegmans Apples, Granola, & Low Fat Vanilla Yogurt, 4.3 OZ (122g) Distributed by: Wegmans Foods Markets, Inc. Rochester, NY 14603 On or before August 18; UPC 7789026737
Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10. The intended use of the Tip Cover Accessory is to provide dielectric insulation over a section of the Monopolar Curved Scissor instrument so that RF energy is only available at the scissor blades. The Monopolar Curved Scissors are intended for endoscopic manipulation of tissue, including: cutting, blunt and sharp dissection, electrocautery. This accessory is to be used with the Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci, da Vinci S and da Vinci Si Surgical Systems Models IS1200, 12000, ISSOQO).
Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T). The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for treatment of the following acute and chronic instabilities or deformities: 1 - degenerative disc disease, 2 - spondylolisthesis, 3 - trauma, 4 - spinal stenosis, 5 - deformities or curvatures, 6 - tumor, 7 - pseudoarthrosis, and 8 - failed previous fusion.
Capsule Neuron Docking Station, a component in the DataCaptor Connectivity System Catalog Number DC-NU-DS-CK The Capsule Neuron Docking Station is a component in the DataCaptor Connectivity System. The Capsule Neuron Docking Station provides connection for the Capsule Neuron UMPC which is a bedside device that enables automatic collection of vital signs data that can connect to the hospital network through a wired Ethernet connection or via a standard 802.11 b/g/n wireless network.
CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in the kit is used in skin prep
CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained in the kit is used in skin prep
CMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep Solution The PV contained in the kit is used in skin prep
CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution
Meijer Brand Mushrooms, imported from The Netherlands Stems & Pieces, DR WT 4-oz and 8-oz sizes/Net Wt. 6.5-oz and 13.25-oz, UPC 7-1373337545-0 and UPC 7-1373337544-3
The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest, IL 60045. For use with a compatible Hospira PCA pump set with injector and a compatible Hospira infusion device.
Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: KC-54020. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: KC-54030. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm Ref: KC-54040. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: KC-54060. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.
Thai Farmer Brand Preserved Star Gooseberry, NET WT 7.0 OZ. Packaged 30 per case. Product labeling reads in part:''***THAI FARMER BRAND PRESERVED STAR GOOSEBERRY*** DISTRIBUTED BY: T.F. FOODS, INC. PARAMOUNT, CA 90723***NET WT. 7.0 OZ***PRODUCT OF THAILAND***''.
''Sirius Dog Treats''. Bone-shaped treats packaged 10 each in a cellophane package
STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD Cassettes are used in conjunction with the STERRAD Sterilizers, and each cassette model is for use only in the matching sterilizer model.
STERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD Cassettes are used in conjunction with the STERRAD Sterilizers, and each cassette model is for use only in the matching sterilizer model.
Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma/fracture. The device is intended for use with either allograft or autograft. The device may be used with a cleared supplemental fixation system based on surgeon discretion and preference.
Product is an aqueous Black/Carpenter Ant, veterinary allergenic extract in liquid form. Product is viled in 10 mL Type 1 glass vials, stoppered with latex stoppers and sealed with a 13 mm aluminum crimped cap.
Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.
Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.
Meal Replacement product is labeled in part: ''***The Perfect Shake***All of the Best***None of the Rest***foru***Dietary supplement***Net wt. 20 oz (1 lb 4 oz) (564 g)***A well balanced blend of old-world plant nutrition.***What's in The Perfect Shake supplement? All of the best, and none of the rest, in amounts that are the right balance for you.***More than just the best ingredients, The perfect Shake supplement is made from the optimal ratio of the right ingredients, scientifically designed to supplement a healthy diet and use along with your weight management program.**The Perfect Shake supplement is as much about what it doesn't contain as what it does. There are no animal proteins (it's vegan). No whey, soy or casein. No ingredients produced using biotechnology. No glutens. No artificial sweeteners like sucralose or aspartame.***Maintaining your ideal energy levels and supporting your weight management goals shouldn't be a challenge; it should be easy, natural, and something anyone can do.***Try The Perfect Shake Supplement for 30 days. If you don't love it, return the empty container for a full refund.***All of the Best***Ancient Grain Blend***Amaranth, Sorghum and Brown Rice***Richest sources of nutrients among grains***Metabolic Support Blend***Use as part of your diet to help promote healthy blood sugar levels***Promotes healthy metabolism* ***SuperFood Blend***With superfoods like spinach and carrot powders***Lycopene - the powerful anti-oxidant***Digestive Blend***Dietary fiber to support your digestive system***Guar gum to provide a gentle laxative***Beneficial bacteria to promote digestive health* ***Natural Flavoring and Sweeteners***NuStevia - sweeter than sugar without the unwanted effects***Natural vanilla flavor***None of the Rest***whole milk***gluten***lactose***processed sugar***fructose***casein protein***processed sugar***fructose***casein protein***synthetics***food dyes***artificial coloring***ingredients produced using biotechnology***artificial sweeteners***artificial flavo
BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone prosthesis designed for placement in and maintenance of the TE (tracheoesophageal) puncture following total laryngectomy. The Blom-Singer Indwelling TEP (tracheoesophageal Puncture) Occluder is indicated for placement in and maintenance of the TE puncture following total laryngectomy when placement, or replacement, of an indwelling prosthesis is performed by a qualified, trained medical professional.
Siemens Uroskop Access. Fluoroscopic, image intensified x-ray system
Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system
Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Response) LABELING: Box Label: REF 8253200 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA***Rx Only***Lot***SN:***'' Top of unit is labeled in part: ''***NIM-Response 3.0***Medtronic***'' Bottom/Underside of unit is labeled in part: ''***5X20mm FA.L., 32mA. 250VAC***REF***MEDTRONIC XOMED INC. JACKSONVILLE, FL USA***'' Cord is labeled in part: ''***Ref.***Mfg Date***Sn***'' The NIM 3.0 Patient Interfaces [REF #'s 8253210 (Pulse), 8253200 (Response), 8253410 (Neuro)] is an EMG Nerve Integrity Monitor intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots.
Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (Neuro). LABELING: Box Label: REF 8253410 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA***Rx Only***Lot***SN:***'' Top of unit is labeled in part: ''***NIM-Response 3.0***Medtronic***'' Bottom/Underside of unit is labeled in part: ''***5X20mm FA.L., 32mA. 250VAC***REF***MEDTRONIC XOMED INC. JACKSONVILLE, FL USA***'' Cord is labeled in part: ''***Ref.***Mfg Date***Sn***'' The NIM 3.0 Patient Interfaces [REF #'s 8253210 (Pulse), 8253200 (Response), 8253410 (Neuro)] is an EMG Nerve Integrity Monitor intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots.
Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253210 (Pulse). LABELING: Box Label: REF 8253210 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA***Rx Only***Lot***SN:***'' Top of unit is labeled in part: ''***NIM-Response 3.0***Medtronic***'' Bottom/Underside of unit is labeled in part: ''***5X20mm FA.L., 32mA. 250VAC***REF***MEDTRONIC XOMED INC. JACKSONVILLE, FL USA***'' Cord is labeled in part: ''***Ref.***Mfg Date***Sn***'' The NIM 3.0 Patient Interfaces [REF #'s 8253210 (Pulse), 8253200 (Response), 8253410 (Neuro)] is an EMG Nerve Integrity Monitor intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots.
Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and distributed by Volcano Corporation, Rancho Cordova, CA. Medical device for use in imaging of histology.

Code Info
Catalog Number 101-05-20; Serial Numbers: 2179820 and 2216759.
Catalog Number: 101-05-30. Serial Numbers:2218601 and 2218603.
Catalog Number: 101-05-40. Serial Numbers:2193123 and 2193124.
Catalog Number: 101-45-20. Serial Numbers:2138948 and 2138950.
Catalog Number: 101-45-30. Serial Numbers:2139027 and 2139028.
Catalog Number: 101-45-20. Serial Numbers:2139099 and 2139100.
Philips HeartStart MRx monitor/defibrillators manufactured prior to June 2012 and used in external transport and Emergency Medical Service (EMS) environments, distributed worldwide
Product Code 5634B with Date codes 8/17/2012-8/20/2012
Product Code 2051 with Date codes 08/14/12-08/17/12
Product Code 4025 with Date codes 8/14/2012-8/17/2012
Rogges Sour Cream Cuke Salad, 2057, 8/7/12
Archer Farms Layered Taco Dip Kits - Taco Dip, Kits, 8/24/2012.
Chef's Kitchen Deluxe Egg Salad, 2044, 8/8/2012-8/15/2012
DF Homemade macaroni Salad, 401140, 8/22/2012
Garden-Fresh Potato Pancakes 0425 08/10/12-08/15/12
Garden-Fresh Bacon Mac & Cheddar Salad base 2209B 08/14/12-08/16/12
Brand, Product name, Product Code and Date Code: Garden-Fresh Tomato Mozzarella Salad Kit 5163 08/04/12-08/10/12
Brand, Product name, Product Code and Date Code: Finest Traditions Tuna Salad Spread 38622 08/20/12-08/25/12 Finest Traditions Tuna Salad Spread 38620 08/25/12 Garden-Fresh Premium Tuna Salad 5101 08/18/12-08/25/12 Market Pantry Tuna Salad 24108 8/18/2012-8/25/2012 Weis Tuna Salad 5345 8/18/2012
Brand, Product name, Product Code and Date Code: Garden-Fresh Family Style Creamy Tuna Salad 5108 8/14/2012-8/17/2012
Garden-Fresh Fresh Mango Salsa 9025 8/26/2012
Garden-Fresh Black Bean Salsa, 6118, 08/25/12; Garden-Fresh Black Bean Salsa, 52587, 8/24/2012
Finest Traditions Fat Free Black Bean Salsa, 38694, 08/15/12-08/22/12
Garden-Fresh Baked Potato Salad Kit, 1071B, 08/13/12-08/20/12
Knowlan's Club Salad Base, 39076, 08/15/12
Copperwood Kitchens Greek Style Pasta Salad, 8103, 8/16/2012 Garden-Fresh Greek Style Pasta Salad 2035 8/13/2012-8/17/2012
Finest Traditions Pea & Cheese Pasta Salad, 38688, 08/15/12-08/22/12
Finest Traditions Rigatoni Pasta Salad, 38666, 08/15/12-08/22/12
Garden-Fresh Ranch Pasta Salad, 2202, 8/13/2012-8/15/2012
Garden-Fresh Seafood Pasta Salad, 5007, 08/14/12-08/20/12
Garden-Fresh Southwestern Pasta Salad, 2046, 08/13/12-08/16/12
Our Own Fettuccine Pasta Salad, 2150, 8/15/2012- 8/20/12
DF Special Recipe Macaroni Salad, 98110, 8/25/2012
Finest Traditions Creamy Cheddar Macaroni , 38888, 08/13/12-08/22/12
Garden-Fresh Family Style Macaroni Salad 2060 8/15/2012-8/17/2012
Garden-Fresh Deluxe Egg Salad, 2043, 8/8/2012-8/15/2012
Garden-Fresh Deviled Egg Salad , 2122, 8/12/2012
Brand, Product name, Product Code and Date Code: Roundy's Old Fashioned Cream Dill Dip, 52603, 09/09/12
Brand, Product name, Product Code and Date Code: Garden-Fresh Sweet and Sour cucumber, 2014, 08/06/12-08/10/12,
Grandpas Sour Cream Cucumbers Salad, 2080, 8/5/2012-8/10/2012 &
Garden-Fresh Cranberry Walnut Red Cabbage Slaw Base, 3028B, 08/16/12-08/20/12
Garden-Fresh Creamy Cole Slaw Dressing , 3200, 09/09/12-09/15/12
1) Garden-Fresh Dixie Cole Slaw, 3007, 8/16/2012-8/17/2012 ; 2) DF Special Recipe Dixie Cole Slaw, 98115, 8/25/2012
Garden-Fresh Amish Country Cole Slaw, 3010, 08/15/12
Finest Traditions Homemade-Style Cole Slaw, 38562, 08/13/12-08/20/12 Finest Traditions Homemade Style Cole Slaw, 38858, 08/13/12-08/20/12
Finest Traditions XTRA Creamy Cole Slaw, 39000, 8/20/2012-8/22/2012
Finest Traditions Creamy Country Cole Slaw, 38554, 08/13/12-08/22/12
Garden-Fresh Black Bean Couscous, 5620, 08/06/12-08/13/12
Garden-Fresh Kidney Bean Salad , 2016, 8/14/2012 - 8/17/2012
Finest Traditions Fat Free Bean Salad, 38644, 08/15/12
Catalog No. 300316A (Lot Nos. - NGVJ1108, NGVJ1712, NGVJ1713, NGVJ1105, NGVJ1714) Catalog No. 898316 (Lot Nos. NGVJ1614, NGVJ1615, NGVJ1616, NGVJ1617) Catalog No. 897414 (Lot No. NGVJ1705) Catalog No. 907618 (Lot No. NGVJ1757) Catalog No. 907600 (Lot No. NGVJ1764)
1) Wawa baby carrots Net Wt 3 oz (85g) Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 16; UPC 2619102517
The letter was issued for all product presently in the field and product that will be released. Specific lot numbers were not indicated in the letter.
There is no code information. The package shows the type of mice and the quantity.
Product not coded. Production date is May 2, 2011.
''126'', ''136'', ''143'' and ''150''. These are the julian dates that the dough was made, baked and packaged.

Product Quantity
264,662 cases and 296,224 individually distributed units (total)
74,667 units of 4-oz and 159,349 units of 8-oz

Reason for Recall
ORTHO ProVue, with a software glitch or defect that could lead to erroneuous results, was distributed.
The recall was initiated because Biosense Webster has become aware of information regarding a potential hazard that may occur during the operation of a Bloom EP Stimulator device in conjunction with RF generators and other electrophysiology (EP) equipment, including the CARTO 3 Electropysiology Mapping System.
HLA typing assay, associated with false negative results, were distributed.
Blood products, labeled with an incorrect expiration date, were distributed.
The firm has tracked a systematic failure in the door cord on the Sun|Dash Radius 252 product line. In some instances when the door cord is installed with little or no slack outside the upper decor piece, the cord has been known to fail causing a short in the wiring at the pivot point in the cord.
During an FDA inspection it was found that the CalDensity Black label and CalDensity White Label with HA product containers did not include the precautionary statement DO NOT FEED TO CATTLE OR OTHER RUMINANTS
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Blood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed
Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood products, which was collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed
Human Corneas, recovered from a donor who had not been properly evaluated, were distributed.
Terumo Cardiovascular Systems (Terumo CVS) received complaints from our Affiliate, Terumo Dubai that the safety monitors were tripping off. Terumo CVS' investigation determined that 8 monitors were manufactured with an underrated circuit breaker due to an error where an associate pulled an underrated circuit breaker from an incorrect inventory location. Since this time, inventory locations have been adjusted to avoid mix-ups of different current rated circuit breaker. Terumo CVS implemented a requirement to ensure that assembly associates verify the values of electrical components in process to avoid such mix ups. At the time the problem was discovered, an NCR was opened to document that all remaining inventory at Terumo CVS had the correct circuit breaker installed. All Safety Monitors at Terumo CVS were verified to have the correct circuit breaker. Terumo CVS received complaints in 2009, at which time corrective action was completed for devices in the field. These corrections were not reported to the agency at that time.
Therapy Cable Connection wear may lead to a malfunction in detection of defibrillation pads/paddles therapy Cables
Blood product, which did not meet acceptable product specifications, was distributed.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
This recall was mandatory by the States. Frozen Oysters from Korea is considered adulterated. First found out by one of our customer in NY called Sunny Seafoods on 5/07/12 asking about the recall. Inspector from NY Dept. of Health notified our customer. Oyster farming area in Korea found to be adulterated.
Blood products, which did not meet the acceptable product specifications, were distributed.
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Blood product, which was collected from a donor who lived in a malarial endemic area, was distributed.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
The feed contains excessive levels of selenium
Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
GE Healthcare has recently become aware of a potential safety issue with respect to the Innova 2121IQ & Innova 3131IQ Systems. While performing a fluoroscopic acquisition with the Innova 2121IQ or Innova 3131IQ systems, there is a potential for loss of usable imaging mode which requires the system to restart in order to recover.
Sunquest is recalling Sunquest Laboratory versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, and 7.0.1 because when the Windows-based merge application is used and the ''Event merge across patients'' option is used, a receiving system (for example a HIS or CoPath system) may interpret the event merge as a full patient merge. This occurs because a trigger from the Laboratory system for the event merge across patients may be formatted exactly the same as the patient-to-patient merge trigger. This may also occur if the application interfacing code has not been modified to process the event merge across patients trigger.
Incomplete seal on sterile packages of product.
The products are contaminated with Listeria monocytogenes.
There is potential for the sterility of the product to be compromised.
There is a possibility that the screw channel that holds the rod in place may be out of tolerance. When the depth of the channel is not deep enough, the rod may not be able to provide ample compression on the insert preventing the screw head from locking down to the bone screw.
Capsule Neuron Docking Station may experience a lost connection, resulting in loss of data or loss of power to the Caspsule Neuron
The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.
The sodium in the product is above the declared value of the sodium stated on the label.
The firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose disconnects/separates resulting in water leakage that can cause damage to property.
Reports of leaking during filling and administration.
The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
The firm initiated a voluntary recall of frozen mice because of possible human exposure to Lymphocytic Choriomenengitis Virus from handling the mice.
Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex.
Products recalled due to undeclared FD&C Yellow # 6.
The wheat germ used by the firm to make their products was recalled by the wheat germ manufacturer because it was potentially contaminated with metal fragments approximately 0.5mm in diameter and 3-15mm in length. The contamination occurred at the raw ingredient manufacturer.
Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System cassettes because the camera used to verify printing on the Sterrad System cassettes was inadvertently disabled. The STERRAD 100S and STERRAD NX System cases were shipped without verification of proper printing.
The firm voluntarily recalled the device after they discovered that the sterilization recommendations on the product insert did not pass sterilization validation.
Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.
Atlas Operations, Inc is recalling Meal Replacement foru Dietary Supplement, Lot R2-981-12, Exp. Date: 7/14 for possible microbial contamination.
Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.
Siemens has discovered a possible hazard to patients or hospital personnel when tilting the Uroskop Access system starting with serial number 6076. When tilting the table on the Uroskop Access table, the motor may become disconnected and the entire table assembly may fall on the floor.
During regular product monitoring, firm became aware of a potential issue with the Mobilett Mira system, (serial numbers 1034, 1038, 1041, 1042, 1043, 1050, 1053, and 1054. During normal clinical operation the center screw on the driving wheel may become loose resulting in system immobilization. There is no risk of the system tipping over or collapsing on the floor, however the system may tilt to the floor on one side.
In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedure. If the delay occurs after a patient has already been anesthetized, the resulting delay could extend the patient's time under anesthesia if time is required to troubleshoot the system or if it is rendered inoperable. Models Ref 8253200 (Response) and Ref 8253410 (Neuro) were distributed in the US and Models Ref 8253200 (Response), Ref 8253210 (Pulse) and 8253410 (Neuro) were distributed internationally.
The display on the system has the potential to change. In house testing eventually identified the unique sequence of events that must occur in order for this issue to manifest itself.