Recalling Firm
LifeSouth Community Blood Centers Inc - Birmingham Region
Community Blood Centers of South Florida, Inc.
Tri-Union Seafoods, L.L.C dba Chicken of the Sea.
Ernimich, Inc. (dba Nina International, Inc.)
Whole Foods Market South Seafood Distribution

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

Distribution Pattern
Illinois; North Carolina; Germany; Switzerland
US Nationwide distribution in the state of IL
Worldwide Distribution - USA including FL, MA, NC, CA, MD, VA, IN, AL, NJ, AZ, OK, MT, NY, OH, IA, MI, TX, WI, GA, IL, TN and NE. Internationally to Switzerland.
Nationwide and Canada, Australia, Germany, Brazil, Austria, United Kingdom, India, Chile, Switzerland, Thailand, Japan
Worldwide distribution: USA (nationwide) and countries of: Australia, Brazil, Canada, Chile, Egypt, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Korea, Mexico, Peru, Republica Argentina, Spain, Switzerland, and Venezuela.
Worldwide Distribution - USA Nationwide including the states: CA, ID, NJ, NY, OH, PA, PR, RI, TN, and TX, FL, and the countries of Italy, Chile and Ecuador
Products are distributed nationwide and Hong Kong
Worldwide Distribution--USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV.
Worldwide Distribution - USA including AZ,CA, FL, IA, IL, IN, MO, NE, NJ, NY, OH, PA, WA. Internationally to Thailand, Canada, Germany, France, UK, Hungary, Netherlands, Russian Fed, and Sweden,
Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, and Europe.
New York, New Jersey, Massachusetts, Illinois, Ohio, and Ontario, Canada
Nationwide Distribution including AZ, AK, CA, CO, DE, DC, FL, GA. ID, IL, IN, IA, KS, KY, LA, MD, ME MA, MS, MO, MT, NE, NJ, NM, NV, NY, NC, OH, OR, PA, RI, SC, TN, TX, VA, WV, and WI
Iowa, Maine, Maryland, Michigan, Minnesota, Missouri, New York, Ohio, Pennsylvania and Virginia
Product was shipped to the following states: AZ, CO, ID, KS, MO, MT, NE, NM, NV,UT & WY.
Nationwide Distribution including AZ, CA, FL, KY, MD, MA, NJ, NY, PA, and TX.
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, Czech Republic, Germany, Italy, Spain, France, United Kingdom, Japan, New Zealand, South Korea, Saudi Arabia, Sweden, Singapore, Slovenia, and Taiwan.
Nationwide in the US: TX, IL, UT, WA, CA, AZ.
Nationwide distribution: USA including states of: AZ, MD, and KS.
The products were sold in Virginia, Maryland and Washington, D.C.
Worldwide Distribution--US (nationwide) including the states of CA, FL, MA, LA, and MI and the countries of Switzerland, Saudi Arabia, Lebanon, Canada and Korea.

Product Description
Red Blood Cells Leukocytes Reduced Irradiated
Medpro Elastomeric Infusion Pump. AccuFlux, Model # CT-0020-100H. Product Usage: The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the user to ensure that the medication is prepared and administered accordance with the drug manufacturers package insert. The devices deliver controlled amounts of medication directly to the intraoperative site for pain management and or antibiotic administration. The devices infuse the medication at an hourly flow rate. Medications are infused intraoperatively and postoperatively through intramuscular or subcutaneous routes. The devices are also intended for controlled delivery of local anesthetics in close proximity to nerves for post operative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous. It is for continuous infusion of medications for general infusion use, including antibiotic delivery and chemotherapy.
Mercer's Ice Cream Old Fashioned Cookie Dough, Half Gallon, (1.89 Liter), UPC 036667 200231
Mercer's Ice Cream Cookies 'N Cream, Half Gallon (1.89 Liter), UPC 036667 200392
Mercer's Ice Cream Cream N' Coffee Fudge, Half Gallon, (1.89 Liter), UPC 074513 003513
IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone most common to orthopedic surgical procedures.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood and Blood Products for Reprocessing
Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)
GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).
GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).
GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).
Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distributed with pressure cuffs of varying sizes as accessories. Affected models include *2100-SX, 3000 series, 2017, 2016, 2015, 2014, 1059, 1059-A, *1059-C, *1058-C, 4000 series, 1100 series, 1060 series, 1080 series, 234 and 246. (* = current production model) All the devices are used in the study and diagnosis of vascular disease and blockages in the upper and lower extremities.
The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection and semi-quantitation of antibodies against the Sm antigen in serum as an aid in the diagnosis of autoimmune disease. The results are reported in ELISA units (EU) per ml determined by comparison to a Calibrator.
Nestle Coffee-Mate Coffee Creamer, Original Flavor, packaged as 3/8 fl oz single serve tubs.50 single serve tubs are packaged in a self dispensing fiberboard box. Four fiberboard boxes are packaged in a case.
''Sazon con Culantro y Achiote'' (seasoning)
Gluten Free Cafe Cinnamon Sesame Bar. The Retail Carton has a UPC 70795-03451 and the Individual Bar has a UPC 70795-03551. The product is labeled in parts: ''***Cinnamon Sesame Bars With Flax Seeds & Roasted Peanuts***gluten free cafe***NET WT .95 OZ (27g); myglutenfreecafe.com; glutenfreechoices.com
Gluten Free Cafe Chocolate Sesame Bar. The Retail Carton has a UPC 70795-03450 and the Individual Bar has a UPC 70795-03550. The product is labeled in parts: ''***Chocolate Sesame Bars With Flax Seeds & Roasted Peanuts***gluten free cafe***NET WT .95 OZ (27g); myglutenfreecafe.com; glutenfreechoices.com
100/120V AC, Advanced Perfusion System Platform (APS) The Terumo Advanced Perfusion System 1 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.
220/240V AC, Advanced Perfusion System Platform (APS) The Terumo Advanced Perfusion System 1 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.
NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component The NexGen system is a semiconstrained, nonlinked condylar knee prostheses. The device is indicated for patients with severe knee pain and disability due to rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis; collagen disorders and/or avascular necrosis of the femoral condyle; post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion, dysfunction or prior patellectomy); moderate valgus, varus or flexion deformities; salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of these devices is to protect both patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter.
Bolthouse Farms Carrot Chips (Croustilles Aux Carottes). No Preservatives. Product of the U.S.A. Net Wt. 16 oz (1 lb) 454 b poids net. UPC 71464 17209 Product was also packed under brand names of Safeway Farms, UPC 21130 70217 and Farm Stand (private label for SuperValue). Bolthouse Farms, Bakersfield, CA
Murray's WAFFLE CONE DIP, NET WEIGHT - 7 lb 8 oz (3.40 kg), Product Item Code 835462, Bar code 0 06847 66003 2. The product is packaged in # 10 cans, 3 cans per case.
Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54
Kimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and controlling patient temperature.
Vicks NyQuil Cold & Flu, Nighttime Relief, 12 FL OZ bottle, Dist. by Proctor and Gamble, Cincinnati, OH 45040. NDC 37000-808-12
Jimmy Dean French Toast & Sausage Sandwich, Net Wt 3.9 oz (110g); a food service individually butcher paper wrapped, fully cooked frozen sandwich; 12 sandwiches per 2.74 lb case; UPC 54500 51434
Kroger Deluxe French Vanilla Magnifique Ice Cream, 48 FL OZ laminated carton. INGREDIENTS: MILK, CREAM, SUGAR***CONTAINS: MILK, EGGS DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202***800-632-6900 or www.kroger.com.
The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001. The generic name is infusion administration set. Labeling indicates ~10 ml, Latex-free Infusion Set with Needle-free Port, One injection Port. Device is single use only, do not resterilize, and is available only by prescription. Device made in U.S.A. by Iradimed Corporation located in Winter Park, FL 32792. Lot LBG001, Exp 07/2016 The MRidium MRI Infusion Pumps and Infusion Sets are intended for general hospital or clinical use by medical professionals whenever it is required to infuse patients with intra-venous or intra-arterial fluids before, during, or after Magnetic Resonance Imaging (MRI) scans. The device is available for sale only upon the order or a physician or other related licensed medical professional, and not intended for any home use applications.
Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy
Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy
Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusion only, GlaxoSmith Kline, Research Triangle Park, NC 27709. Made in England, NDC 0007-4401-06
Chicken of the Sea Solid White Tuna in Water, 7 oz., 48 cans per case (case: 6 sets of multi-unit packs of 8 cans each), UPC 4800000097, case UPC 4800076127.
Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 Metered Actuations, For Oral Inhalation with Advair HFA actuator only, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0715-20.
Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST, NDC 0173-0715-22, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709.
Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) rheumatoid arthritis, 3) correction offunctional deformity, 4) treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques, 5) revision of previously failed total arthoplasty.
Ground Hot Pepper Chillies, 5 oz. plastic jars, 24 jars/case; jars labeled in part ***Imported and distributed by Nina International Inc., P.O. Box 2176, Hyattsville, MD 20784***Product of Ghana***
The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated Vertex Max Drill Guide Set is intended to be used with a Medtronic Computer Assisted Surgery System to help assist with screw placement during spine surgical procedures. The device is reusable and requires sterilization according to product labeling. .
Almondine Wedding Cookies sold by the pound.
Wedding Cookies (Baked Fresh In-Store), Whole Foods Market, sold by the pound.
United Dairy Farms brand Oatmeal Cookie Overload Ice Cream 3 gallon, corrugated square
Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: 63304-827-90
Atorvastatin Calcium Tablets, 20 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: 63304-828-90
Atorvastatin Calcium Tablets, 40 mg, a) 90 tablets per bottle, b) 500 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: a) 63304-829-90, b) 63304-829-05.

Code Info
Product coding is listed as Catalog Number: Lot Number and are as follows: 118-0005:126564; 118-30016:127375; 118-30018:AP6A08; 118-30020:AP6A07.
Catalog # 720-240, Lot # T0401, Expiration Date: November 18. 2012
UPC code on the 50 count box: 50000-351107. A production code on the 50 count box: 214651186 with a time stamp from 2:30 to 3:34. Best buy date on 50 count box: Mar 2013
Best By dates: 16APR13 BU1, 17APR13 BU1, 15MAR13 BU1, 22SEP12 BU1, 22AUG12 BU1, 23AUG12 BU1, 29JUN12 BU1, 24MAY12 BU1, 25APR12 BU1, and 02MAR12 BU1
Best By dates: 01MAY13 BU1, 30APR13 BU1, 18MAR13 BU1, 20OCT12 BU1, 19OCT12 BU1, 17OCT12 BU1, 16OCT12 BU1, 04JUL12 BU1, 03JUL12 BU1, 26APR12 BU1, and 21MAR12 BU1.
Catalog number: 801763 and all serial numbers
Catalog number: 801764 and all serial numbers
Part Number Lot Number 4511 201008270110
Bolthouse Farms Best if Used by NOV 12 2012 04 T xxxx BF212 J11 and Best If used by Nov 13, 2012 04T XXXX BF212 J12. Safeway Farms Best if Used by Nov 13, 2012 06 T xxx S2682 BF 212 J12 286. Farm Stand Best If Used by Nov 12-12-2012, 04 t xxxx BF 212 J11-12.
Incorrect back label: UPC 54500 51434, item 51434, code date 12292P1; Case SKU 51366
The device Lot Code is LBG001. The ''L'' indicates facility, Las Piedras Facility. The ''B'' indicates year manufactured, 2012. The ''G'' indicates month manufactured, July. The ''001'' indicates the sequential lot build, restarts at 1 every month.
Arch handles with a serial number less than 1204001, or between 1111001 0 and 1111 0069
Best By Date Can Code October 1 2016 BE11D ASWAP October 1 2016 BE11D ASWAP October 1 2016 BE14D ASWAP October 1 2016 BE14D ASWAP October 1 2016 BE15D ASWAP October 1 2016 BE15D ASWAP October 1 2016 BE1AD ASWAP October 1 2016 BE1BD ASWAP October 1 2016 BE1CD ASWAP October 1 2016 BE1CD ASWAP October 1 2016 BE1CD ASWAP October 1 2016 BE1DD ASWAP October 1 2016 BE1DD ASWAP October 1 2016 BE1ED ASWAP October 1 2016 BE1AD ASWAP October 1 2016 BE1ED ASWAP October 1 2016 BE1BD ASWAP October 1 2016 BE1CD ASWAP October 1 2016 BE1ED ASWAP October 1 2016 BE15D ASWAP October 1 2016 BE1BD ASWAP October 1 2016 BE1CD ASWAP October 1 2016 BE1DD ASWAP October 1 2016 BE1ED ASWAP October 10 2016 BEA1D ASWAP October 10 2016 BEA1D ASWAP October 10 2016 BEAED ASWAP October 11 2016 BEBAD ASWAP October 11 2016 BEB1D ASWAP October 11 2016 BEBDD ASWAP October 11 2016 BEB1D ASWAP October 11 2016 BEB2D ASWAP October 11 2016 BEB3D ASWAP October 11 2016 BEB3D ASWAP October 11 2016 BEB3D ASWAP October 11 2016 BEB3D ASWAP October 11 2016 BEB4D ASWAP October 11 2016 BEB5D ASWAP October 11 2016 BEB5D ASWAP October 11 2016 BEBAD ASWAP October 11 2016 BEBAD ASWAP October 11 2016 BEBAD ASWAP October 11 2016 BEBAD ASWAP October 11 2016 BEBBD ASWAP October 11 2016 BEBBD ASWAP October 11 2016 BEBCD ASWAP October 11 2016 BEBCD ASWAP October 11 2016 BEBDD ASWAP October 11 2016 BEBDD ASWAP October 11 2016 BEBDD ASWAP October 11 2016 BEBED ASWAP October 11 2016 BEBED ASWAP October 11 2016 BEBED ASWAP October 12 2016 BECCD ASWAP October 12 2016 BEC4D ASWAP October 12 2016 BECAD ASWAP October 12 2016 BECBD ASWAP October 12 2016 BECCD ASWAP October 12 2016 BEC1D ASWAP October 12 2016 BEC5D ASWAP October 12 2016 BECBD ASWAP October 12 2016 BECCD ASWAP October 2 2016 BE21D ASWAP October 2 2016 BE21D ASWAP October 2 2016 BE22D ASWAP October 2 2016 BE22D ASWAP Oct
Catalog Number: 192411 and Lot Number Identification: 244800

Product Quantity
349 units (Domestic: 270 units - Foreign: 79 units)

Reason for Recall
Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed.
Blood products, which were collected from a donor who traveled to malarial endemic areas, were distributed.
Blood products, which were collected from a donor in which donor suitability were not adequately determined, were distributed.
Blood products, collected from a donor who did not have a complete physical examination, 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 were not adequately determined, were distributed
Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being reclassified by the Agency as a Class I. The recall was initiated because First Medical Source has confirmed that these lots may have a higher flow rate than specified. The use of this product may lead to over-administration of drug solutions to the patients. The product may fail to meet nominal flow rate of 15%.
The ice cream product contained soy lecithin (the ingredient statement listed lecithin only).
Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.
Blood product, which was washed with an incorrect wash solution, was distributed.
Blood products, collected from a donor who was permanently deferred, were distributed.
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Blood product, which did not meet acceptable product specifications, was distributed.
Blood product, which did not meet the acceptable product specifications, was distributed.
Blood products, for which quality control and distribution of products did not meet specifications, were distributed.
Blood products, which were collected from a donor who gave history which warranted deferral or follow up, were distributed.
Marketed without an approved NDA/ANDA: Samantha Lynn Inc. is recalling Reumofan Plus Tablets because it contains undeclared drug ingredients making it an unapproved drug.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade.
Parks Medical Electronics, Inc. was made aware of two incidents where an air supply tube from their PARKS PVR unit was inadvertently connected to an IV in the patient's arm instead of into the blood pressure cuff.
Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.
Nestle Professional Vitality initiated a recall on 10/9/12 of their Nestle COFFEE-MATE Original Liquid Creamer Singles due to a manufacturing error that causes the creamer to become acidic.
Undeclared colors: FD&C Yellow #5, Yellow#6 and Red #40
Gluten Free Cafe Cinnamon Sesame Bar is recalled due to the potential to be contaminated with Salmonella. The recalled Roasted peanuts from Sunland Inc., were used as ingredients in this product.
Gluten Free Cafe Chocolate Sesame Bar is recalled due to the potential to be contaminated with Salmonella. The recalled Roasted peanuts from Sunland Inc., were used as ingredients in this product.
Terumo Cardiovascular System (TCVS) has received reports of a situation where users experienced a total loss of functionality for some System 1 units. The reports indicate that the units went blank and shut down with no sign of power and battery backup did not initiate. The result is all pumps stop, with no safety system functionality, and the battery would not be activated. The user would be limited in the ability to provide adequate cardiopulmonary support. The potential injury is high should this apparently rare event occur and the event with recovery steps is not described in the operator manual.
Zimmer is initiating a lot specific recall of the NexGen Stemmed Nonaugmentable Tibial Component due to the devices being processed through a manufacturing cleaning operation that was operating outside of the validated parameters. As a result, the devices may contain residual particulate from the manufacturing process. Risks include: Allergic reaction due to the foreign material or late onset allergic reaction and accelerated polyethylene wear caused by third body particles.
The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve 4511, which fits 11mm light guides, actually contain Pinnacle Cure Sleeves that fit 7mm or 8mm light guides (part number 4500).
Random sampling conducted by the North Carolina Department of Agriculture and Consumer Protective Services had a positive result for Salmonella in Bolthouse Carrot Chips.
The product contains undeclared allergens milk and soybean oil due to mislabeling.
Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product
Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately.
Labeling Illegible: Portions of the product labeling in the area of the dosing directions, the warnings & other information sections is obscured.
Some of the Jimmy Dean French Toast & Sausage Sandwiches were mislabeled on the back label with an ingredients statement for another product, resulting in undeclared allergens, egg and soy, not listed on the label.
Nestle is recalling Nesquik Chocolate Powder because certain lots of its ingredients, calcium carbonate, may be contaminated with Salmonella.
The firm was notified that the ice cream may contain Pecans and, if eaten, could result in severe allergic reaction in persons sensitive to Pecans
Iradimed Corporation is recalling MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001 because a section of the device does not meet specifications.
Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle
Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.
Chicken of the Sea is recalling Solid White Tuna in Water because the product label has undeclared soy allergen.
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem.
Food may be contaminated with Salmonella.
Medtronic is recalling certain Vertex Max Drill Tubes which are used with the StealthStation System due to a defect related to the internal threading for component set up.
Product contains undeclared allergen: almonds .
Product contains undeclared allergens: pecans.
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.