• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of April 9, 2014

  • Print
  • Share
  • E-mail
-
Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Cryoprecipitated AHF 16LM97945, 16LM98022, 16LM98027, 16LM98092, 16LP16059, 16LP16063, 16LP16067 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 16LM98041, 16LM98034, 16LM98026, 16LZ31873, 16LT37791, 16LT37776, 16LT37786, 16LP16066, 16LZ31901, 16LM98096, 16LM98091, 16LT37787, 16LM98092, 16LM98022, 16LT37818, 16LT37784, 16LM98177, 16LP16148, 16LP16141, 16LT37816, 16LM98027, 16GJ50978, 16GJ50865, 16LT37797, 16LM98023, 16GJ50862, 16LT37777, 16LM98180, 16LP16063, 16LT37829, 16LM98206, 16LP16142, 16LP16064, 16LP16058, 16LP16067, 16LM98082, 16LM98025, 16LM98081, 16LT37798, 16LM98300, 16LZ31880, 16LP16048, 16LP16061, 16LM98188, 16LT37802, 16LT37827, 16LT37783, 16LP16059, 16LP16149, 16LT37803,  ...
More
Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced Irradiated 16LM97945, 16LZ31888, 16LZ31900, 16LZ31899 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American National Red Cross (The)
Biologics Platelets Leukocytes Reduced 16LM98299, 16LT37777, 16LM98293, 16LT37798, 16LM98300, 16LZ31897, 16LT37803, 16LZ31888, 16LT37796, 16LZ31894, 16LZ31895, 16LT37785, 16LT37800, 16GJ50975, 16LT37791, 16LT37776, 16LZ31901, 16LT37784, 16GJ50865, 16GJ50978, 16LT37801 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American National Red Cross (The)
Biologics Plasma Cryoprecipitate Reduced 16LM97945, 16LM98079 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American National Red Cross (The)
Biologics Cryoprecipitated AHF, Pooled 16LM98082, 16LT37816, 16LT37827, 16LT37829 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American National Red Cross (The)
Biologics Fresh Frozen Plasma 16LT37801, 16LZ231892, 16LT37777, 16LT37798, 16LM98300, 16LT37802, 16LT37783, 16LT37803, 16LT37796, 16LT37785, 16LT37800, 16LT37788, 16LT37791, 16LT37786, 16LT37787, 16LT37784, 16LT37797 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American National Red Cross (The)
Food Peanut Butter Cookies none Class I Butter Creek Farms, Inc. is recalling peanut butter cookies due to undeclared peanut, wheat, soy, egg. The firm sold single product or combined this product with other products in gift boxes from the website http://cowchipcookies.com/index.htm. Butter Creek Farms, Inc.
Food Mock Baby Ruth Cookies none Class I Butter Creek Farms, Inc. is recalling Mock Baby Ruth Cookies due to undeclared peanut, egg, wheat, soy, wheat, and milk. The firm sold single product or combined this product with other products in gift boxes from the website http://cowchipcookies.com/index.htm. Butter Creek Farms, Inc.
Food Nutty Cow Chips, Nutty Calf Chips, and Nutty Bull Chips cookies none Class I Butter Creek Farms, Inc is recalling Nutty Cow Chip Cookies due to undeclared Walnut, Egg, Wheat, Soy, and Milk (butter was listed). The firm sold single product or combined this product with other products in gift boxes from the website http://cowchipcookies.com/index.htm. Butter Creek Farms, Inc.
Food White Chocolate Macadamia Cookie none Class I Butter Creek Farms, Inc is recalling White Chocolate Macadamia Cookie due to undeclared Macadamia nut, Egg, Wheat, Soy, and Milk. The firm sold single product or combined this product with other products in gift boxes from the website http://cowchipcookies.com/index.htm. Butter Creek Farms, Inc.
Food Cow Chip, Calf Chip and Bull Chip are Chocolate Chip Cookies none Class I Butter Creek Farms, Inc. is recalling Chocolate Chip Cookies (Cow Chip, Calf Chip and Bull Chip) due to undeclared Wheat, Soy, Egg, Milk (butter is listed). The firm sold single product or combined this product with other products in gift boxes from the website http://cowchipcookies.com/index.htm. Butter Creek Farms, Inc.
Food Double Chocolate Amaretto Cookies none Class I Butter Creek Farms, Inc. is recalling Double Chocolate Amaretto Cookies due to undeclared Wheat, Soy, Egg. The firm sold single product or combined this product with other products in gift boxes from the website http://cowchipcookies.com/index.htm. Butter Creek Farms, Inc.
Food Lemon Sugar Cookies none Class I Butter Creek Farms, Inc. is recalling Lemon Sugar Cookies due to undeclared Wheat and Egg. The firm sold single product or combined this product with other products in gift boxes from the website http://cowchipcookies.com/index.htm. Butter Creek Farms, Inc.
Food M&M Cookies none Class I Butter Creek Farms, Inc. is recalling M&M Cookies due to undeclared Wheat, Egg, Milk, and Soy. The firm sold single product or combined this product with other products in gift boxes from the website http://cowchipcookies.com/index.htm. Butter Creek Farms, Inc.
Food Snickerdoodle Cookies none Class I Butter Creek Farms, Inc. is recalling Snickerdoodle Cookies due to undeclared Wheat and Egg. The firm sold single product or combined this product with other products in gift boxes from the website http://cowchipcookies.com/index.htm. Butter Creek Farms, Inc.
Food Oatmeal Raisin Cookies none Class I Butter Creek Farms, Inc. is recalling Oatmeal Raisin Cookies due to undeclared Wheat and Egg. The firm sold single product or combined this product with other products in gift boxes from the website http://cowchipcookies.com/index.htm. Butter Creek Farms, Inc.
Food Sprinkle Cookies none Class I Butter Creek Farms, Inc. is recalling Sprinkle Cookies due to undeclared Wheat, Egg and Soy. The firm sold single product or combined this product with other products in gift boxes from the website http://cowchipcookies.com/index.htm. Butter Creek Farms, Inc.
Food Winn-Dixie Chocolate Flavored Drink Mix NET WT 30 OZ (1 LB 14 OZ) 851 G Distributed by: Winn-Dixie Stores, Jacksonville, FL 32254 Expiration Date JUL1415B Class I Product may contain incorrect formula mixture, which could result in an undeclared milk allergen. Winn-Dixie Logistics, Inc.
Drugs Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-02. Lot #s: F300737 Exp. February 2015, F300743 Exp. February 2015 Class III Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station. Lupin Pharmaceuticals Inc.
Drugs Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-03. Lot #s: F300736 Exp. February 2015, F300740 Exp. February 2015, F300741 Exp. February 2015 Class III Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station. Lupin Pharmaceuticals Inc.
Devices Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ventilators, used for ventilation during short term transport of patients within a hospital. all lots Class I The battery capacity of the optional PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected. Draeger Medical Systems, Inc.
Devices RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy. MODEL #(s): 2.5, 3.0, 3.5 and 4.0; VERSIONS: 2.5.1.89, 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9 Class II Potential for dose errors due to software program errors. RAYSEARCH LABORATORIES AB
Devices RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software Model#: 4.30; Version: 4.0.2.9; 3D-CRT optimization or Fallback Planning Licenses Class II RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy. RAYSEARCH LABORATORIES AB
Biologics Source Plasma TT0308385, TT0298307, TT0298890, TT0299106, TT0299722, TT0300033, TT0300655, TT0300997, TT0301648, TT0301996, TT0302655, TT0302965, TT0303520, TT0303853, TT0304415, TT0304711, TT0305341, TT0305807, TT0306289, TT0306773, TT0307060, TT0307523, TT0307909, TT0308792, TT0309310, TT0309776, TT0310290, TT0310736, TT0311210, TT0311619, TT0312146, TT0312600, TT0313131, TT0318444, TT0339890, TT0313612, TT0314151, TT0314608, TT0315068, TT0315474, TT0315951, TT0297947, TT0316332, TT0316791, TT0317203, TT0317478, TT0317919, TT0318850, TT0319314, TT0319732,  ...
More
Class II Blood products, collected from a donor who did not have a complete physical examination, were distributed. DCI Biologicals Temple Terrace, LLC
Devices Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: 03111873180 as a part of the following systems: 1. 03337103001, cobas b 221<1>Roche OMNI S1 system 2. 03337111001, cobas b 221<2>Roche OMNI S2 system 3. 03337154001,cobas b 221<6>Roche OMNI S6 system 4. 03337138001, cobas b 221<4>Roche OMNI S4 system Product Usage: Usage: Blood Gas and Electrolytes Analyzer c. Classification Name: Fully automated Critical Care Analyzer for the measurement of pH, Blood gases, electrolytes, Hematocrit, hemoglobin, glucose, lactate, urea/BUN, total hemoglobin, Oxygen saturation, oxy - deoxycarboxy and methemoglobin all serial numbers Class II Reference electrode used beyond the guaranteed in-use 52 week lifetime,may leak and potentially cause erroneous pH and/or sodium results. Other Ion parameters are not affected. Roche Diagnostics Operations, Inc.
Devices Artis Zee Angiographic x-ray systems. Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959. Class II An inappropriate cable connection was assembled for certain Artis zee systems. which may cause a system failure and possibly lead to a restricted maneuverability of the gantry system. Siemens Medical Solutions USA, Inc
Drugs QVAR® (beclomethasone dipropionate HFA), C4 INHALATION AEROSOL in Aluminum Cylinders, Mktd by: Teva Respiratory, LLC, Horsham, PA 19044 Mfd by: 3M Drug Delivery Systems, Northridge, CA 91324. lot 120088, exp.3/2014, NDC 59310-202-40, 40 mcg,8.7g / 120 metered inhalations, lot 120491, exp. 10/2014, NDC 59310-175-41,40 mcg,7.3g / 100 metered inhalations Class III Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point Teva Pharmaceuticals USA
Devices Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes. 152718, 152003, 152007, 151963, 152081, 151693, 152131, 152318, 105792, 105570, 152778, 151052, 152363, 152472, 152195, 153022, 152689, 152640, 152642, 152663, 152680, 152782, 152796, 152829, 152862, 152962, 153030, 153125, 153244, 153270, 153211, 153296, 152834, 152596, 151354, 151353, 152664, 151200, 151823, 151822, 151610, 152026, 152027, 152692, 151276, 152856, 151106, 152877, 152986, 152810,  ...
More
Class II The problem is that the "static tolerances" from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values. Elekta, Inc.
Food Tom Yom Soup, 24 oz. plastic cups, packed 6 cups\cardboard case, and labeled in part ***Manufactured by Whole Foods Market, Landover, MD 20785***UPC 00000601467*** Use by 4/8/14 Class I Ready to eat soup lists whey in the ingredient statement, but the product does not declare milk as the source for the allergen. Whole Foods Market Mid-Atlantic Kitchen
Devices Infantino Squeeze & Teethe Monkey, "Go Gaga Squeeze & Teether Coco the Monkey". Non-Fluid Filled Teething Ring. Model # 206-647. All lot numbers are included in the scope of the recall Class II Infantino initiated this voluntary recall of all lots of Infantino Squeeze & Teethe Monkey, "Go Gaga Squeeze & Teethe Coco the Monkey", Model Number 206-647, because the tail of the monkey may pose a choking hazard to young children. Infantino LLC
Devices IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing. The VersaCell system is a robotic sample-moving device that supports an interface to a number of laboratory analysis systems, such as the IMMULITE 2000 IMMULITE 2000: 10380062, 10380061,10380079, 10380065, 10360210, 10283632 IMMULITE 2000XPi: P010053/S007; 10373214 VersaCell: 10380063, 10389945, 10380064, 10287115, 10793839 Class II There is a potential for incorrect results to be reported from processing of a sample tube. Siemens Medical Solutions Diagnostics
Food Requeson Mexicana Part-Skim Ricotta, 15 oz., packaged in a plastic cup, Distributed by Roos Foods Inc., Kenton, DE 19955, UPC code 095548003415, (Ingredients: Pasteurized milk, whey, skim milk, cultured milk, solids, carrageenan, salt, potassium sorbate, (preservative)) . Requeson Mexicana Part-Skim Ricotta, 16 oz. packaged in a rigid plastic container (Clamshell), Distributed by Roos Foods Inc., Kenton, DE 19955, UPC code 095548003415, (Ingredients: Pasteurized milk, whey, skim milk, cultured milk, solids, carrageenan, salt, potassium sorbate, (preservative)) . all lots and expiration dates,UPC code 095548003415 Class I Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility. Roos Foods Inc
Food Santa Rosa de Lima Queso Duro Blando (Hard Cheese), packaged in 14 oz and 8 oz clear, rigid plastic containers (Clamshell), Manufacturado por (manufactured for) Roos Foods Inc., Kenton, DE 19955, Plant No. 10-5436, UPC codes 095548003194 and 095548003118. (Ingredients: Pasteurized milk, nonfat dry milk, potassium sorbate, salt, cultures, calcium chloride, natamycin (mold inhibitor) and titanium dioxide (whitener)). all lots and expiration dates, UPC codes 095548003194 and 095548003118 Class I Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility. Roos Foods Inc
Food Mexicana Brand Queso Cotija Molido packaged in 1, 6 oz rigid plastic containers (Clamshell), Distributed/Distribuido por: Roos Foods Inc., DE 19955, UPC code 095548001435. (Ingredients: Pasteurized whole milk, salt, rennet, calcium, lactic acid). all lots and expiration dates, UPC code 095548001435 Class I Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility. Roos Foods Inc
Food Santa Rosa de Lima Queso Rallado Aserrin (Grated Cheese) Queso Duro Viejo packaged in a 16 oz Plastic Pouch, Manufactured by Roos Foods, Inc. Kenton, DE 19955, Plant No. 10-5436, Distributed by: Roos Foods Distributors, 645 Lofstrand Lane, Rockville, MD 20850, UPC code 095548003460. (Ingredients: Pasteurized milk, whey, skim milk, cultured milk solids, carrageenan, salt, potassium sorbate, (preservative)). all lots and expiration dates,UPC code 095548003460 Class I Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility. Roos Foods Inc
Food Santa Rosa de Lima Queso de Huerta (Fresh Cheese), 12 oz. packaged in a rigid plastic container (Clamshell), Manufacturado y Distribuido por (manufactured and distributed for) Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 095548003859. (Ingredients: Pasteurized whole milk, salt, rennet, calcium, cultures, natamycin). all lots and expiration dates, UPC code 095548003859 Class I Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility. Roos Foods Inc
Food Queso Fresco Anita, 16 oz., packaged in a rigid plastic container (Clamshell), Kenton, DE 19955 Plant No. 10-5436. all lots and expiration dates Class I Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility. Roos Foods Inc
Food Mexicana Brand Queso Fresco Fresh Cheese, 16 oz. Wrapped in cellophane, ) Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 095548003330 (Ingredients: Cultured and pasteurized milk, salt). all lots and expiration dates, UPC code 095548003330 Class I Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility. Roos Foods Inc
Food Queso Fresco Amigo Brand Round Fresh Cheese, 16 oz. wrapped in cellophane, Manufactured by: Roos Foods, Inc. Kenton, DE 19955, Plant No. 10-5436, UPC code 095548003316. (Ingredients: Pasteurized whole milk, salt, rennet, calcium, lactic acid). all lots and expiration dates, UPC code 095548003316 Class I Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility. Roos Foods Inc
Food Santa Rosa De Lima Queso Fresco Round Fresh Cheese, packaged in 80 oz (5 lbs) cellophane wrapping, Manufacturado por (manufactured for) Roos Foods Inc., Kenton, DE 19955 Plant No. 10-5436,UPC code 095548003569. (Ingredients: Pasteurized whole milk, salt, rennet, calcium, cultures). Santa Rosa de Lima Queso Fresco Round Fresh Cheese, 16 oz. Wrapped in cellophane, Manufacturado por (manufactured for) Roos Foods Inc., Kenton, DE 19955 Plant No. 10-5436,UPC code 095548003569. (Ingredients: Pasteurized whole milk, salt, rennet, calcium, cultures). all lots and expiration dates,UPC code 095548003569 Class I Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility. Roos Foods Inc
Food Mexicana Cuajadita Casera (Fresh Cheese), 16 oz. wrapped in cellophane on a styrofoam tray, Roos Foods Inc., Kenton, DE 19955 Plant No. 10-5436, UPC code 095548003651. (Ingredients: Cultures, pasteurized milk, salt, natamycin (mold inhibitor)). Santa Rosa de Lima Cuajadita Casera (Fresh Cheese), 16 oz. wrapped in cellophane on a styrofoam tray, Roos Foods Inc., Kenton, DE 19955 Plant No. 10-5436, UPC code 095548003699. (Ingredients: Cultures, pasteurized milk, salt, natamycin (mold inhibitor)). Amigo Brand Cuajadita Casera (Fresh Cheese), 16 oz., wrapped in cellophane on a styrofoam tray, Roos Foods Inc., Kenton, DE 19955 Plant No. 10-5436, UPC code 095548003224. (Ingredients: Cultures, pasteurized milk, salt, natamycin (mold inhibitor)). all lots and expiration dates, UPC code 095548003651, UPC code 095548003699, UPC code 095548003224 Class I Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility. Roos Foods Inc
Food Mexicana Brand Cuajada Fresca (Fresh Cheese) 16 oz., packaged in a rigid plastic container (Clamshell), Roos Foods Inc., Kenton, DE 19955 Plant No. 10-5436, UPC code 095548003606. (Ingredients: Cultures, pasteurized milk, salt). Amigo Brand Cuajada Fresca (Fresh Cheese), 16 oz. Packaged in a rigid plastic container (Clamshell), Mfd. By: Roos Foods Inc., Kenton, DE 19955 Plant No. 10-5436, UPC code 095548003064. (Ingredients: Cultured and pasteurized milk, salt). all lots and expiration dates, UPC code 095548003606, UPC code 095548003064 Class I Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility. Roos Foods Inc
Food Santa Rosa de Lima Cuajada Fresca (Fresh Cheese) , 16 oz packed in a rigid plastic container (Clamshell), Roos Foods Inc., Kenton, DE 19955 Plant No. 10-5436, UPC code 095548003538. (Ingredients: Pasteurized whole milk, enzymes, rennet & salt). all lots and expiration dates, UPC code 095548003538 Class I Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility. Roos Foods Inc
Food Santa Rosa de Lima Cuajada en Terron (Fresh Cheese Curd), 16 oz packaged in a plastic bag, Roos Foods Inc., Kenton, DE, 19955, Plant No. 10-5436, UPC code 095548003033. (Ingredients: Pasteurized whole milk, enzymes, rennet & salt). Santa Rosa de Lima Cuajada en Terron, packaged in a 10 lb vacuum packaged plastic bag, Roos Foods Inc., Kenton, DE, 19955, Plant No. 10-5436, UPC code 095548000551. (Ingredients: Pasteurized whole milk, enzymes, rennet & salt). Santa Rosa de Lima Cuajada en Terron Fresh Cheese Curd, 16 oz., packed in a rigid plastic container (Clamshell) Roos Foods Inc., Kenton, DE, 19955, Plant No. 10-5436, UPC code 095548003026. (Ingredients: Pasteurized whole milk, enzymes, rennet & salt). all lots and expiration dates, UPC code 095548003033, UPC code 095548000551, UPC code 095548003026 Class I Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility. Roos Foods Inc
Food Santa Rosa de Lima Crema Salvadorena Cultured Sour Cream, 80 oz. (5lbs), packaged in a Plastic Tub, Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 095548003934. Santa Rosa de Lima Crema Salvadorena Culture Sour Cream, Grade A, 16 oz., packed in a plastic jar, Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 095548003507. Santa Rosa de Lima Crema Salvadorena Cultured Sour Cream, Grade A, 30 oz., packaged in a plastic jar, Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 095548003873. Santa Rosa de Lima Crema Salvadorena Cultured Sour Cream , Grade A, 16 oz., packaged in a plastic pouch, Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 095548000483. Santa Rosa de Lima Crema Salvadorena (Cultured Sour Cream), Grade A, 14 oz., packaged in a plastic bag, Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 095548003842. Santa Rosa de Lima Crema Salvadorena Cultured Sour Cream , Grade A, 30 oz., packaged in a plastic bag, Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 095548003873. (Ingredients: Cream, milk, water, salt, nonfat dry milk, cultured skim milk powder, gelatin, stabilizers (carrageean gum, disodium phosphate), color (annato extract), dairy cultures). all lots and expiration dates, UPC code 095548003934,UPC code 095548003507, UPC code 095548003873, UPC code 095548000483, UPC code 095548003842, UPC code 095548003873. Class II Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility. Roos Foods Inc
Food Crema Pura Mexicana Brand (Crema Mexicana) Cultured Sour Cream, packaged in a 80 oz Plastic Tub, Grade A, packaged in a 80 oz (5lbs) Plastic Tub, Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 095548000247. La Original Crema Pura Mexicana Brand (Crema Mexicana) Cultured Sour Cream , packaged in a 16 oz White Plastic Jar with a yellow plastic lid, Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 095548000285. Crema Pura Mexicana Brand (Crema Mexicana) Cultured Sour Cream , Grade A, 30 oz., packed in a plastic jar, Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 095548000230. Crema Pura Mexicana Brand (Crema Mexicana) Cultured Sour Cream , Grade A, 16 oz., packed in a plastic pouch, Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 095548000407. (Ingredients: Cream, milk, salt, nonfat dry milk, cultured skim milk powder, gelatin, stabilizers (carrageean gum, disodium phosphate), color (annato extract), dairy cultures). all lots and expiration dates, UPC code 095548000247, UPC code 095548000285, UPC code 095548000230, UPC code 095548000407. Class II Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility. Roos Foods Inc
Food Amigo Brand Crema Centroamericana Cultured Sour Cream, Grade A, 16 oz., packed in a plastic jar, Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 09554800079. (Ingredients: Cream, milk, salt, nonfat dry milk, skim milk powder, gelatin, stabilizers (carrageean gum, disodium phosphate), color (annato extract), dairy cultures). all lots and expiration dates, UPC code 09554800079 Class II Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility. Roos Foods Inc
Food Santa Rosa de Lima Mantequilla de Bolsa Tradicion Centroamericana, 15 oz., packaged in a plastic bag, Manufactured by Roos Foods, Inc., UPC code 095548002159. (Ingredients: Cream, milk, water, salt, nonfat dry milk, cultured skim powder, gelatin, stabilizers (carrageean gum, disodium phosphate), color (annato extract), dairy cultures). all lots and expiration dates,UPC code 095548002159 Class II Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility. Roos Foods Inc
Food La Chapina Crema Guatemalteca Guatemalan Style Cream, 16 oz. packaged in a plastic bag, Distribuido por: Roos Foods Distributors, 645 Lofstrand Lane, Rockville, MD 20850, UPC code 095548000414. (Ingredients: Cream, milk, water, salt, nonfat dry milk, cultured skim milk powder, gelatin, stabilizers (carrageean gum, disodium phosphate), color (annato extract), dairy cultures). all lots and expiration dates, UPC code 095548000414 Class II Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility. Roos Foods Inc
Drugs Tivicay (dolutegravir) Tablets 50 mg, 30 Tablet Bottles, Rx Only. Manufactured for: ViiV Health, TRP, NC 27709; by: GlaxoSmithKline, Research Triangle Park, NC 27709. Made in Japan. NDC 49702-228-13 Lot #: 3ZP2210 Sub-lot A, Expiry: 10/15 Class III Cross Contamination with Other Products: Product contains Promecta (eltrombopag). Viiv Healthcare Company
Food Mrs. Griffin's Hot Barbecue Sauce, Net 1 Gallon (13.785L), Made by Griffin Barbecue Sauce, Inc., Macon GA 31206 Lot codes: 14016 and 14038. Class I Product contains undeclared allergen: milk (as a preservative). Bar-Jim Inc., dba Mrs. Griffins Barbecue Sauce
Food Mrs. Griffin's Original Barbecue Sauce, Net 32 Fl.oz. (946 mL), Made by Griffin Barbecue Sauce, Inc., Macon GA 31206 Lot codes: 14016 and 14038. Class I Product contains undeclared allergen: milk (as a preservative). Bar-Jim Inc., dba Mrs. Griffins Barbecue Sauce
Food Mrs. Griffin's Hickory Smoke Barbecue Sauce, Net 32 Fl.oz. (946 mL), Made by Griffin Barbecue Sauce, Inc., Macon GA 31206 Lot codes: 14016 and 14038. Class I Product contains undeclared allergen: milk (as a preservative). Bar-Jim Inc., dba Mrs. Griffins Barbecue Sauce
Devices Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0. System Code Serial Number DC040898989 DC120785335 DC040801181 DC020893846 DC020893848 DC030936872 DC030938113 DC030938457 DC070948475 DC070948476 DC100956827 DC120961879 DC011064963 DC090775316 DC021070642 DC061086404 DC091095147 DC060767368 DC010887574 DC110782289 DC120787279 DC061132521 DC061132519 DC081138659 DC081138643 DC081139521 DC081139520 1755367 DC080815579 DC070813153 1685358 1134FMM0UW DC090777023 15 DC030936391  15 1708792 1708999 0841BD200F 3/1133FMM0C2 DC110781164 DC060764615 DC060764372 0908QAC00B 0926QAD063 0925QAD076  ...
More
Class II Philips Medical Systems have recently determined that a software nonconformance can cause incorrect beam geometry. This issue affects Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0 manufactured from 09/29/09 to 12/01/2013. Philips Medical Systems (Cleveland), Inc.
Devices TDWorkstation version 11.01.A or higher. TDWorkstation receives patient results from a connected instrument and sends them to a Laboratory Information System (LIS). version 11.01.A or higher Class III If a conflict occurs between a Demography Query and a Result Transmission by the instrument, the TDWorkstation could send an incorrect patient demography to an instrument. Technidata S.A.
Food Evropa Zele Bonboni Jelly Candy Net Wt. 500 g Imported in USA by: Fast-Pak Trading Inc., 375 County Ave., Secaucus, NJ 07094 UPC 5310002480041 Lot # L3505131 Class III NYSDAM laboratory analysis report has revealed that Zele Bonboni Jelly Candy contains unallowed green colorant chlorophillyn. Fast-Pak Trading Inc.
Food Popsicle Orange Cherry Grape 20 pops Net 33 fl oz Unilever Englewood Cliffs, NJ 07632 USA UPC 077567121301 best before dates of JUN0315GBV, JUN0415GBV, JUN0515GBV and JUN0615GBV Class I Unilever United States, Inc. is voluntarily recalling a limited number of 20-count boxes of Popsicle brand Orange, Cherry and Grape flavored ice pops because they may have been inadvertently exposed to milk, which is not listed as an ingredient on the label. Unilever United States, Inc.
Devices AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter Jet. Removable functional orthodontic appliances that are to modify the growth of the jaws in a prescribed growth pattern. All Devices/Codes Manufactured from August 28, 2013 to November 6, 2013 Class II The Lock Nut component of the Jet appliances may be missing the screw collar, which serves as a mechanical stop to prevent over-tightening in appliance assemby. Without this collar, an over-tightened lock nut may stop the piston assembly from moving freely, subsequently preventing intended movement of the teeth. Allesee Orthodontic Appliances
Food Ideal Protein Double Chocolate Brownie. Individually wrapped, sold in boxes of 7. Lot Numbers: 30213, 30913, 31113, 31613, 31813, 32313, 33213, 02814, 03614 Class II Possible contamination with thin metal fragments. Laboratories Cop Inc
Biologics Blood and Blood Products for Reprocessing W088413540238 Class II Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. Blood Bank Of Hawaii
Biologics Red Blood Cells Leukocytes Reduced W224313304965 Class II Blood product, collected from a donor who lived with an individual who had Hepatitis B, was distributed. Houchin Community Blood bank
Biologics Red Blood Cells Leukocytes Reduced W037712087577 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. Hoxworth Blood Center
Biologics Red Blood Cells Leukocytes Reduced Irradiated W037712010967 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. Hoxworth Blood Center
Food 8 oz. Tuscan Style Combo on Tomato Basil Spread sandwiches individually wrapped in clear plastic wrap sold under the Fresh To Go brand. "Best By" codes: Friday 0228, Saturday 0301, Sunday 0302, Monday 0303, Tuesday 0304 Class I "Fresh To Go Tuscan Style Combo on Tomato Basil Bread" sandwiches contain undeclared pine nuts (tree nuts). H.C. Schau & Son
Drugs Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx Only, 60 capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7542-06 Lot #: 48D001, Exp. 5/2015; 48D002, Exp. 9/2015 Class II Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage. Teva Pharmaceuticals USA
Drugs Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 30 Capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA, 18960, NDC 0093-7543-56 Lot #: 49D001, Exp. 4/2015; 49D002, Exp. 6/2015; 49D003, Exp. 7/2015; 49D004, 49D005, 49D006, Exp. 9/2015; 49D007, Exp. 10/2015 Class II Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage. Teva Pharmaceuticals USA
Drugs Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 30 Capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA, 18960, NDC 0093-7544-56 Lot #: 50D003, Exp. 2/2015; 50D004, 50D005, Exp. 3/2015; 50D006, Exp. 5/2015; 50D010, Exp. 6/2015; 50D028, Exp. 9/2015; 50D029, 50D031, Exp. 10/2015; 50D032, 50D033, Exp. 11/2015 Class II Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage. Teva Pharmaceuticals USA
Food Belmont Premium Ice Cream, Chocolate Chip Cookie Dough, All Natural, 1.5 Quarts (1.42 L), Nutrition Facts....., Ingredients: Skim milk, Cream, Sugar, Cookie dough pieces (unenriched wheat flour, sugar, butter (cream, salt), brown sugar, water, corn oil, fructose, corn syrup solids, salt, vanilla extract, sodium bicarbonate, coconut oil) corn syrup, chocolate flakes (sugar, coconut oil, cocoa processed with alkali, butter oil, soy lecithin, natural flavor, whey flavor base ( brown sugar, water, natural flavor, molasses, salt) egg, carob bean gum, guar gum, carrageenan, annatto (color), Contains: milk, wheat , egg, soy Distributed by ALDI Inc. Batavia, IL 60510, UPC code 4149816310 date code 13340 and 13341, Best by Date: Dec. 7, 2014 Class I may contain undeclared nut allergen. House Of Flavors, Inc.
Food Asian Taste (Brand) Green Tea Pumpkin Seeds, 8 oz., UPC 673367418186. UPC 673367418186. Class III Walong Marketing, Inc. initiated the recall of Asian Taste Green Tea Pumpkin Seeds because it contains the ingredient sodium copper chlorophyllin, not permitted for use in food or foold products sold in the U.S. Walong Marketing, Inc.
Food Net Food Turkey Dried Apricots Net Weight 16.1 oz (454 g) Thunderbolt Export & Imports 743 Fairview Avenue. Suit :2 Arcadia, CA 91007 USA UPC 8697445250019 none. Class I NYSDAM Analysis has revealed the presence of undeclared sulfites in Dried Apricots. Net Food Import and Export llc.
Biologics Platelets W035214030217P; Class III Blood Product, collected from a donor whose health history screening was not adequately performed, was distributed. Carter BloodCare
Devices 3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M" Steri-Vac" Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for INDOOR USE ONLY. Model SKU Starting S/N Ending S/N 5XL 70-2007-2303-2 721115 721309 5XL 70-2007-2304-0 820174 820201 5XL 70-2007-2575-5 780066 780102 8XL 70-2006-8493-7 350136 350268 8XL 70-2006-8498-5 450016 450027 4XL 523122, 522205, 522502, 522287, 522655. Class II Recently, 3M received a single report of a potential exposure to Ethylene Oxide (EO) at a hospital installation involving 3M" Steri-Vac" Gas Sterilizers. The cause was traced to a rare situation involving a failure of the EO cartridge puncture assembly. This assembly was only in production during the period November 10, 2006 through December 14, 2007 and in service during the period February 7, 2007 and September 23, 2008. 3M Company - Health Care Business
Food Kirkland Signature brand Real Sliced Fruit, Item # 527069. The UPC on the master cardboard case is 0 96619 52706 9. Each cardboard case consists of 20 plastic pouches (7.41 oz): 10 pouches of Fuji Apple Slices, 5 pouches of Strawberry Banana Slices, and 5 pouches of Fuji Apple Slices with Cinnamon. The UPC on Fuji Apple Slices pouch is 0 96619 27072 9; The UPC Strawberry Banana Slices pouch is 0 96619 27070 5; The UPC Fuji Apple Slices with Cinnamon pouch is 0 96619 27071 2; Product is distributed by: Costco Wholesale Corp., P.O.Box 34535, Seattle, WA 98124-1535, 1-800-774-2678, www.costco.com Best Before: FEB142015 to MAR112015. It interprets as February 14, 2015 to March 11, 2015; Class I Oregon Freeze Dry, Inc. is recalling Kirkland Signature brand Real Sliced Fruit due to contamination of Salmonella. Oregon Freeze Dry Inc
Devices Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalog # 6265-5113 , Left Size #4: catalog #6265-5104 , and Right Size #4: catalog #6265-5114; Stryker Howmedica Osteonics Hip Implants. v40 Hip Stem -Right Size # 3: catalog # 6265-5113 lot code #43317101, v40 Hip Stem -Left Size # 4: catalog #6265-5104 lot code #43316801, lot code 43316901, v40 Hip Stem - Right Size #4: catalog #6265-5114 lot code #43113901 Class II Stryker received a report from the field indicating that a citation TMZF HA 132 degrees neck angle V40 Hip Stem - Left Sze # 4 was identified in a packaging associated with a citation TMZF HA 132 degrees Neck Angle V40 Hip Stem - Right Sze #3. Stryker Howmedica Osteonics Corp.
Devices Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result. Product Code PCDB1 - Lot number - GGG157 Product Code PCDT1 - Lot number - GGG158 Product Code PCDJ1 - Lot number -GGG159 Class II The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination. Ethicon, Inc.
Devices Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe (Esaote product 7348). Provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. Model number 10433816 - ACUSON P3000 Ultrasound System; Model numbers 10852384 - P300 PA 320E transducer. Serial numbers: 105 106 114 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 148 149 150 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 178 186 187 188 189 193 194 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 257 258 259 260 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 318 319 320 321 322 323 324 325 330 331 334 336 337 339 340 341 342 343 344 345 347 348 349 350 351 352 353 354 355 356 357 358 359 360 361 362 363 364 365 366 367 368 369 371 373 374 375 377 378 379 380 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396 400 401 402 403 404 405 406 407 408 409 410 411 412 413 414 415 416 417 418 421 422 423 424 425 426 427 428 429 430 431 432 433 434 435 436 437 438 439 440 441 442 443 444 445 446 447 448 449 450 451 452 453 454 455 456 457 458 459 460 461 462 463 464 465 466 467 468 469 470 471 472 475 476 477 478 479 480 481 482 483 484 485 486 487 488 489 490 491 492 493 494 495 496 497 498 501 506 507 508 509 510 511 512 513 515 516 518 519 520 521 522 526 527 529 530 535 536 537 538 539 540 541 542 544 545 546 547 548 549 550 551 552 553 554 555 556 557 558 559 560 561 562 563 564 565 566 567 568 569 596 597 598 601 602 603 604 605 606 607 608 610 614 615 616 617 618 619 620 621 622 624 627 628 629 630 633 634 635 636 637 638 639 640 641 642 643 644 646 647 648 650 651 652 653 654 655 656 657 659 660 661 662 663 664 665 666 667 668 669 670 671 672 674 675 676 678 679 680 681 682 683 684 685 686 687 689 693 694 696 697 698 699 704 706 707 709 710 711 712 713 718 719 720 721 722 723 724 725 727 728 729 730 731 732 733 734 737 739 743 745 746 747 748 749 750 751 752 753 754 755 757 758 759 760 761 762 763 764 765 766 767 768 769 770 771 772 773 775 776 777 778 779 782 783 784 785 791 792 793 794 795 796 797 798 800 801 806 807 808 810 811 812 814 815 816 817 818 819 821 822 823 824 825 826 827 828 829 830 832 834 835 836 837 838 839 840 841 842 843 845 847 848 853 854 855 856 857 858 860 861 862 863 864 865 866 872 879 881 890 892 893 894 895 896 897 898 900 901 902 903 904 909 910 911 912 913 914 919 920 929 933 934 935 936 937 938 939 940 941 942 943 944 945 946 947 948 949 950 951 952 957 958 959 960 961 962 963 964 965 967 969 970 972 973 974 975 976 977 979 980 981 985 986. Class II ACUSON P300 ultrasound systems using the PA230 transducer with a user-defined preset which includes the 100% setting for output power could cause the transducer surface temperature to exceed the maximum allowable limit. Siemens Medical Solutions USA, Inc.
Devices Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator. System Software Version 02.10.02.00 or Higher Class II Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used ZOLL Medical Corporation
Food Macaroni and cheese packaged in plastic bags, 12 oz. to a bag, and sold under the Sweet Street Desserts brand. Cases of product contain 36 bags for a total case weight of 27 lbs. Product Code: B254A1 Class I Mac & Cheese Shells (Product Code B254A1) sold under the Sweet Street Desserts brand in 12 oz. plastic bags is being recalled due to the presence of Listeria monocytogenes. Perfect Pasta
Devices Weck Vista Universal Laparoscopic Port, Size 5/10mm x 100mm, Catalog No. 405910, Weck Vista Universal Laparoscopic Port, Size 5/10/12mm x 100mm, Catalog No. 405912; Weck Vista Universal Laparoscopic Port, Size 5/10/12mm x 125mm, Catalog No. 40591213. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. Lots  Catalog No. 405910 - 01G1200242, 01G1200242, 01G1200341, 01J1200100, 01J1200100, 01J1200378, 01J1200461, 01K1200266, 01K1200171, 01K1200266, 01L1200182, 01A1300139, 01A1300139, 01B1300050, 01D1300318, 01E1300139, 01E1300217, 01E1300432; Catalog No. 405912  01J1200462, 01K1200129, 01K1200377, 01K1200596, 01K1200611, 01K1200611, 01L1200369, 01L1200369, 01L1200369, 01A1300106, 01A1300106, 01A1300106, 01E1300218, 01E1300311, 01F1300135, 01F1300079; Catalog No. 40591213- 01J1200416, 01K1200612, 01L1200160,  ...
More
Class II Complaints of leakage of insufflation gas through the device. Teleflex Medical
Devices 10mm Weck Vista Cannula-only, Catalog No. 405910C, 12mm Weck Vista Cannula-only, Catalog No. 405912C. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. Lots - Catalog No. 405910C - 01G1200243, 01J1200226, 01L1200368, 01A1300177, 01D1300107, 01E1300140, 01E1300435, Catalog No. 405912C - 01J1200384, 01K1200725, 01L1200352, 01D1300319 Class II Complaints of leakage of insufflation gas through the device. Teleflex Medical
Devices 5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405910R; 5/10/12 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405912R. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. Lots - Catalog No. 40591OR - 01J1200009, 01J1200234, 01J1200380, 01K1200142, 01M1200251, 01A1300140, 01A1300376, 01A1300419, 01A1300370, 01A1300179, 01A1300419, 01A1300373; Catalog No. 405912R - 01H1200064, 01K1200379, 01K1200621, 01L1200370, 01M1200071, 01M1200252, 01A1300170, 01A1300201, 01A130042001A1300545, 01F1300136 Class II Complaints of leakage of insufflation gas through the device. Teleflex Medical
Devices 5/10 mm Weck Vista Universal Cannula, Catalog No. 405910RC; 5/10/12 mm Weck Vista Universal Cannula, Catalog No. 405912RC. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. Lots - Catalog No. 405910RC - 01J1200010, 01J1200242, 01K1200070, 01A1300141, 01B1300052, 01D1300319; Catalog No. 405912RC - 01G1200244, 01M1200020, 01M1200068, 01A1300546, 01A1300559 Class II Complaints of leakage of insufflation gas through the device. Teleflex Medical
Devices 5/10/12 mm x 100mm Weck Vista Universal Cone Open Access, Catalog No. 405933. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. Lots - Catalog No. 405933 - 01L1200353, 01F1300080 Class II Complaints of leakage of insufflation gas through the device. Teleflex Medical
Devices 5/10 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No. 410944, 5/10 Weck Vista Universal Balloon Open Access Port - Long Length (100mm), Catalog No. 410944L; 5/10 Weck Vista Universal Balloon Open Access Port - Short Length (53mm), Catalog No. 410944S; 5/10/12 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No. 412944; 5/10/12 Weck Vista Universal Balloon Open Access Port - Long Length (100 mm), Catalog No. 412944L. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. Lots  Catalog No. 410944 - 01K1200601, 01K1200623, 01L1200355, 01L1200378, 01A1300203, 01D1300412, 01J1200241, 01K1200066, 01K1200622; Catalog No. 410944L - 01J1200219, 01K1200067, 01K1200600, 01L1200056, 01L1200354, 01A1300202, Catalog No. 410944S - 01L1200460, 01K1200619, 01L1200515, 01E1300137; Catalog No. 412944  01J1200241, 01K1200066, 01K1200622; Catalog No. 412944L - 01J1200231, 01K1200597, 01K1200618, 01K1200728, 01A1300178, 01D1300316,  ...
More
Class II Complaints of leakage of insufflation gas through the device. Teleflex Medical
Devices Pressure Monitoring Tubing, PM6006. Pressure Monitoring Tubing (PM series) is used between the manifold and transducer as a conduit to transmit the fluid pressure of the patient to the pressure transducer. Lot Number H591335 Class II The products are labeled as sterile but were not sterilized. Merit Medical Systems, Inc.
Devices Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO. Lot Number H574228 Class II The products are labeled as sterile but were not sterilized. Merit Medical Systems, Inc.
Devices Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A fixed attachment on a tooth which holds an archwire during orthodontic treatment. Part Number 449-6212, Lot Number 121359169. Class II Ormco Corporation inititated recall of U2R Titanium Orthos (0.22+9/+9/0), Part Number 449-6212, Lot Number 121359169, because the color ID dot was marked on the wrong tie-wing of the brackets. Ormco/Sybronendo
Drugs HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-254-01 Lot 120407, Exp 01/14; Lot 121337 Exp 03/14; Lot 122054, Exp 05/14; Lot 122598, Exp 06/14; Lot 130125, Exp 12/14 Class II Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source. American Health Packaging
Drugs HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01 Lot 120757, Exp. 02/14; Lot 121104, Exp 03/14; Lot 122055, Exp 05/14; Lot 123038, Exp 07/14; Lot 125115, Exp 11/14 Class II Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source. American Health Packaging
Show all Code Info
-
-