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U.S. Department of Health and Human Services

Enforcement Report - Week of January 20, 2016

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Veterinary Chicken Tender Chunks 5 lb bag, 6- 5 lb bags/case, and 10 lb bag All UPC Package Codes; Manufacture Date: 05/06/2014 to 01/7/2015 Class I Listeria monocytogenes was found in retail surveillance sample collected by the State of Michigan. The firm was notified and initiated a recall and contacted customers via telephone, press release and letters to be issued. J.J. Fuds, Inc.
Veterinary Beef Tender Chunks 5 lb bag, 6- 5 lb bags/case, and 10 lb bag All UPC Package Codes; Manufacture Date: 05/06/2014 to 01/7/2015 Class I Listeria monocytogenes and Salmonella was found in retail surveillance sample collected by the State of Michigan. The firm was notified and initiated a recall and contacted customers via telephone, press release and letters starting on 1/13/2015. J.J. Fuds, Inc.
Veterinary Duckling Tender Chunks 5 lb bag, 6- 5 lb bags/case, and 10 lb bag All UPC Package Codes; Manufacture Date: 05/06/2014 to 01/7/2015 Class I The product may be contaminated with Listeria monocytogenes and Salmonella. L. mono and Salmonella were detected in other varieties processed at the firm in retail surveillance samples collected by the State of Michigan. The firm was notified and initiated a recall and contacted customers via telephone, press release and letters starting on 1/13/2015. J.J. Fuds, Inc.
Devices Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery. 1) Model 22035 , VVC NAVIGATION SOFTWARE CRANIAL 5.0 , Serial Numbers: 22035-103911-004 , 22035-103953-001 , 22035-103977-001 , 22035-103982-002 , 22035-103987-001 , 22035-103988-001 , 22035-104566-001 ; 2) Model 22040 , VV NAVIGATION SOFTWARE CRANIAL 4.0 , Serial Numbers: 22040/18820 , 22040/21370 , 22040/26909 , 22040/36997 , 22040-103675-006 , 22040-103687-009 ,  ...
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Class I Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccuracies arising from individual steps of a complex navigation procedure that may cause an inaccurate display of instruments by the navigation system compared to the actual patient anatomy. Brainlab AG
Food A BIT OF A BITE SALSA HEINEY HOT SALSA NET WT. 128 OZ INGREDIENTS: DICED TOMATOES***FRESH ZUCCHINI, FRESH ONIONS***FRESH JALAPENO PEPPERS***FRESH HABANERO PEPPERS. A Bit of Bite Salsa 1243 Nouvelle Drive Miamisburg, OH 45342 UPC 6 42125 95415 0 Lot# 24325 Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food A BIT OF A BITE SALSA MELISSA MEDIUM NET WT. 128 OZ INGREDIENTS: DICED TOMATOES***FRESH ZUCCHINI, FRESH ONIONS***FRESH JALAPENO PEPPERS, FRESH HABANERO PEPPERS. A Bit of Bite Salsa 1243 Nouvelle Drive Miamisburg, OH 45342 UPC 6 42125 95416 7 Lot# 253255 Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food A BIT OF A BITE SALSA SARAH SWEET NET WT. 128 OZ INGREDIENTS: DICED TOMATOES***FRESH ZUCCHINI, FRESH ONIONS***FRESH JALAPENO PEPPERS. A Bit of Bite Salsa 1243 Nouvelle Drive Miamisburg, OH 45342 UPC 6 42125 95417 4 Lot # 263245 Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food A BIT OF A BITE SALSA THREE SISTERS NET WT. 128 OZ INGREDIENTS: DICED TOMATOES***FRESH ZUCCHINI, ORGANIC BLACK BEANS, FRESH CORN***FRESH JALAPENO PEPPERS***FRESH HABANERO PEPPERS. A Bit of Bite Salsa 1243 Nouvelle Drive Miamisburg, OH 45342 UPC 6 42125 95418 1 Lot# 27315 Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food Abruzzi's Hot Peppers in oil 15 Fl Oz (444 ml) Manufactured For: Abruzzis Hot Peppers, LLC, 371 Marwood Drive, S.E. Warren, Ohio 44484 (330) 883-7933 UPC 8 51071 00500 1 Lot #377205, 377285 &377295. Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food Barney's Hot Peppers 16 oz (443 ml) Ingredients: Hot Peppers, Canola Oil, Garlic, Oregano, Salt, Acidic Calcium Sulfate Distributed by: Barney's Hot Peppers 2061 Elm Road Warren, Ohio 44483 330-964-2922 UPC # 7 01807 99994 7 Lot # 437305, 43835 & 433315. Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food BINO'S ITALIAN HOT PEPPERS Ingredients: Hungarian hot peppers w/seeds, onions, vinegar, garlic, sugar, Bell peppers, tomato sauce, tomato puree, salt and olive oil. NET WT 16 oz UPC 8 67752 00013 5 NET WT 32 oz UPC 8 67752 00011 1 16 oz Lot # 263245 32 oz Lot # 253255 Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food BINO'S ITALIAN SWEET PEPPERS Ingredients: Bell peppers, onions, vinegar, garlic, sugar, tomato sauce, tomato puree, salt and olive oil. NET WT 16 oz UPC 8 67752 00012 8 NET WT 32 oz UPC 8 67752 00010 4 16 oz Lot # 253255, 32 oz Lot # 253255 Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food Cafe 422 HOT PEPPERS in oil INGREDIENTS Hungarian Hot Peppers***Manufactured & Hand Packed by: Café 422 4422 Youngstown Rd SE Warren, Ohio 44484 330.369.2422 16 oz UPC 8 60557 00010 2 & 32 oz UPC 8 60557 00011 9 Lot # 467285 Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food Cleveland Pickle Original Garlic Dill 16 oz (454 g) Ingredients: Cucumbers, Water***Manufactured For: CLEVELAND PICKLE 850 EUCLID AVE. CLEVELAND OH 44114 216-575-1111 UPC 8 67051 00001 0 Lot # 48875 Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food Cleveland Pickle Spicy Garlic Dill 16 oz (454 g) Ingredients: Cucumbers, Water***Habanero Peppers***Manufactured For: CLEVELAND PICKLE 850 EUCLID AVE. CLEVELAND OH 44114 216-575-1111 UPC 8 67051 00001 0 Lot # 48875 Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food DUTCH COUNTRY KETTLES HOMEMADE Pickled Beets Ingredients: Beets, Water, Vinegar, Sugar, Salt. Dutch Country Kettles 6732 Pavey Road. Leesburg, OH 45135 1-937-780-6718 1 Pint (1 lb. 3oz) 538g UPC 6 98241 12224 9 & 1 Quart (32 oz) 907g UPC 6 98241 14444 9 Lot # 633305 & 635285 Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food HERBERT'S chow-chow Hot New Weight 12.8 oz (363g) Ingredients: Cabbage***Manufactured for: The All-American Relish Company. North Canton OH 44720 330-842-0168 UPC 8 57025 00270 6 Lot # 66295 Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food HERBERT'S chow-chow Mild New Weight 12.8 oz (363g) Ingredients: Cabbage***Manufactured for: The All-American Relish Company. North Canton OH 44720 330-842-0168 UPC 8 57025 00270 6 Lot #'s 75225, 76815 Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food HERBERT'S chow-chow Original New Weight 12.8 oz (363g) Ingredients: Cabbage***Manufactured for: The All-American Relish Company. North Canton OH 44720 330-842-0168 UPC 8 57025 00270 6 All codes Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food House MADE Sriracha Sauce NET WT. 8 oz (237 mL) INGREDIENTS: THAI CHILIES, DISTILLED VINEGAR, SUGARS, GARLIC, MOLASSES, KOSHER SALT. www.housemadesriracha.com UPC 6 12524 99999 1 Lot# 52485 Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food Keim's Garden Harvest tomato salsa 1 PT (14 oz 397g) Ingredients: tomatoes, onions, peppers, herbs***Manufactured by: Keim's Garden Harvest (937) 515.4518 2232 Honeysuckle Lane Wellston OH 45692 mild UPC 6 09722 32345 1 medium UPC 6 09722 32343 7, hot UPC 6 09722 32344 4 Mild Lot # 106295, Medium All Codes, Hot Lot #: 86305 Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food Keim's Garden Harvest pickled beets Ingredients: red beets, water, sugar, vinegar, spices, salt. Manufactured by: Keim's Garden Harvest (937) 515.4518 2232 Honeysuckle Lane Wellston OH 45692 14 oz UPC 6 09722 32336 9, 32 oz UPC 6 09722 32339 0 Lot # 56295-5625 Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food Keim's Garden Harvest pickled red beet eggs Ingredients: eggs, water, vinegar, sugar, salt***beet juice, red #40*** Manufactured by: Keim's Garden Harvest (937) 515.4518 2232 Honeysuckle Lane Wellston OH 45692 1 PT (17 oz 502 ML) UPC 6 09788 83455 7, 32 oz 6 09788 83457 4 Lot# 2465 Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food Keim's Garden Harvest pickled white eggs Ingredients: eggs, water, vinegar, sugar, salt. Manufactured by: Keim's Garden Harvest (937) 515.4518 2232 Honeysuckle Lane Wellston OH 45692 1 PT (17 oz 502 ML) UPC 6 09788 83461 8, 32 oz 6 09788 83456 4 Lot# 16815 Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food Keim's Garden Harvest pickled zesty mustard eggs Ingredients: eggs, water, vinegar, sugar, salt***yellow #5, red #40*** Manufactured by: Keim's Garden Harvest (937) 515.4518 2232 Honeysuckle Lane Wellston OH 45692 1 PT (17 oz 502 ML) UPC 6 09788 83464 9, 32 oz 6 09788 83459 5 All Codes Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food Kiem's Garden Harvest black bean salsa 1 PT (14 oz 397g) Ingredients: beans, corn, tomato***Manufactured by: Keim's Garden Harvest (937) 515-4518 Honeysuckle Lane Wellston, OH UPC 6 09722 32347 5 All Codes Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food Kiem's Garden Harvest corn relish 1 PT (14 oz 397g) Ingredients: corn, peppers, celery***Manufactured by: Keim's Garden Harvest (937) 515-4518 Honeysuckle Lane Wellston, OH 45692 Mild UPC 6 09722 32335 2 Hot UPC 6 09722 32349 9 Lot #14715, Lot # 13715 Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food Kiem's Garden Harvest sweet & tangy citrus salsa 1 PT (14 oz 397g) Ingredients:tomatoes, onions***lemon juice concentrate, lime juice concentrate***Manufactured by: Keim's Garden Harvest (937) 515-4518 2232 Honeysuckle Lane Wellston, OH 45692 UPC 6 09722 32346 8 All Lots Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food PATTY'S PEPPERS HUNGARIAN HOT & SWEET PEPPERS Mom's Original Recipe NET WT 16 oz & 32 oz Ingredients: Hungarian Hot and Sweet Peppers, Garlic, Canola Oil, Vinegar, Salt, Oregano. pattspeppers.com UPC 7 48252 07478 2 Lot #'s: 39855, 393255 & 394105. Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food PATTY'S PEPPERS HUNGARIAN HOT & SWEET PEPPERS Uncle Joe's Original Recipe NET WT 16 oz & 32 oz Ingredients: Hungarian Hot Wax Peppers, Garlic, Vinegar, All Natural Ketchup, Sugar, Canola Oil, pattyspeppers.com UPC 7 48252 07486 7 Lot# 40855, 404105, 403255 & 406295. Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food RJ's DIAVOLO SAUCE WITH PEPPERS 25 oz INGREDIENTS: ground unpeeled vine-ripened tomatoes, tomato puree, tomato past, Hungarian hot wax peppers, Cubanelle peppers, fresh sweet onions, fresh garlic,***Manufactured for: RJ's Pepper Pantry Warren, OH 44484 Phone 330-765-2863 Mild UPC 8 53827 00403 0, Medium Hot UPC 8 5327 00404 7, Hot UPC 8 53827 00405 4 All Lots. Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food RJ's PEPPERS IN OIL 12 OZ. (340G) INGREDIENTS: PEPPERS, CANOLA OIL***Manufactured for: RJ's Pepper Pantry Warren, OH 4484 Phone: 330-766-2863 Mild UPC 8 53827 00401 6, Medium Hot UPC 8 53827 00402 3, Hot UPC 8 53827 00400 9 All Lots. Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food ROASTED MEDITERRANEAN PEPPER RELISH 16 Fl Oz (355 ml) MANUFACTURED FOR RUST BELT PEPPER CO P.O. BOX 36014 CANTON, OHIO 44718 330.323-4735 INGREDIENTS: Imported Roasted Red Peppers***UPC 8 11975 01109 6 Lot# 576235, 57885 Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food ROASTED MEDITERRANEAN SPICY PEPPER RELISH 16 Fl Oz (355 ml) MANUFACTURED FOR RUST BELT PEPPER CO P.O. BOX 36014 CANTON, OHIO 44718 330.323-4735 INGREDIENTS: Imported Roasted Red Peppers***Habanero Pepper. UPC 8 63131 00011 6 Lot# 58885, 586235 & 58495, Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food SEASONAL SELECTIONS SUGAR & SPICE GOURMET BEETS NET WT 16 OZ (1 lb) 453g INGREDIENTS: Beets, Vinegar, Sugar, Whole Allspice, Salt, Cinnamon Sticks SEASONAL SELECTIONS P.O. BOX 251 Waynesville, OH 45060 UPC 8 57596 00308 9 All codes Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Food Keim's Garden Harvest pickled spicy jalapeno eggs Ingredients: eggs, water, vinegar, sugar, salt, spices, peppers, pepper oil, yellow #5, red #40*** Manufactured by: Keim's Garden Harvest (937) 515.4518 2232 Honeysuckle Lane Wellston OH 45692 1 PT (17 oz 502 ML) UPC 6 09788 83460 1, 1 QT (32 oz 946 ML) 6 09788 83458 8 All codes Class II The firm was manufacturing acidified foods without a license. Garden Harvest
Biologics Red Blood Cells W121615163441 Class II Blood product, for which donor screening was incorrectly performed for a prior deferral due to HCV testing, was distributed. The Blood Connection, Inc.
Devices Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm Part #11-162709 9mm Lots: 329750, 404380, 487400, 767120, 951680 Part # 11-162711 11mm Lots: 329760, 505030, 505050 Part # 11-162713 13mm Lots: 837750, 977460 Part # 11-162715 15mm 772410, 837780, 897070, 951810 Part # 11-162717 17mm Lots: 311410, 410500, 535530, 712800, 728080, 829580 Class II PMMA is listed as a material on the label but the product does not contain PMMA. Biomet, Inc.
Devices Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10kg (22 lb). The T-piece resuscitator circuit is a component used in conjunction with the T-piece resuscitator devices Neo-Tee Resuscitator: Part # 1050800 Unique Device ID # 10641043508004 Lot #s less  ...
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Class II Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit and consequent failure to ventilate the patient. Mercury Enterprises, Inc. dba Mercury Medical
Biologics Apheresis Platelets, Leukocytes Reduced, Irradiated W115115170245O Class II Blood product, which did not meet acceptable product specifications, was distributed. LifeSouth Community Blood Centers, Inc.
Biologics Red Blood Cells, Leukocytes Reduced W200615853917; W200614282752; W200614228755; W200614184782; W200614041782; W200613146951; W200613034452 Class II Misbranded red blood cells were distributed. American National Red Cross The
Food Fancy Chinook (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67292 6 Any production codes starting with OC. The last date of distribution of recalled products was September 2015. Class II Product has the potential to be contaminated with Clostridium botulinum. Sockeye Suzys Fish LLC
Food Fancy Spring Chinook (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67412 8 Any production codes starting with OC. The last date of distribution of recalled products was September 2015. Class II Product has the potential to be contaminated with Clostridium botulinum. Sockeye Suzys Fish LLC
Food Peppered & Smoked Chinook (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67282 7 and 7 48252 67302 2. Any production codes starting with OC. The last date of distribution of recalled products was September 2015. Class II Product has the potential to be contaminated with Clostridium botulinum. Sockeye Suzys Fish LLC
Food Peppered & Smoked Coho (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67212 4 Any production codes starting with OC. The last date of distribution of recalled products was September 2015. Class II Product has the potential to be contaminated with Clostridium botulinum. Sockeye Suzys Fish LLC
Food Peppered & Smoked Steelhead, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67332 9 Any production codes starting with OC. The last date of distribution of recalled products was September 2015. Class II Product has the potential to be contaminated with Clostridium botulinum. Sockeye Suzys Fish LLC
Food Peppered & Smoked Sockeye, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67232 2 Any production codes starting with OC. The last date of distribution of recalled products was September 2015. Class II Product has the potential to be contaminated with Clostridium botulinum. Sockeye Suzys Fish LLC
Food Smoked Catfish, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67252 0 Any production codes starting with OC. The last date of distribution of recalled products was September 2015. Class II Product has the potential to be contaminated with Clostridium botulinum. Sockeye Suzys Fish LLC
Food Smoked Chinook (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67282 7 Any production codes starting with OC. The last date of distribution of recalled products was September 2015. Class II Product has the potential to be contaminated with Clostridium botulinum. Sockeye Suzys Fish LLC
Food Smoked Coho (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67222 3 Any production codes starting with OC. The last date of distribution of recalled products was September 2015. Class II Product has the potential to be contaminated with Clostridium botulinum. Sockeye Suzys Fish LLC
Food Smoked Garlic Chinook (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67222 3 Any production codes starting with OC. The last date of distribution of recalled products was September 2015. Class II Product has the potential to be contaminated with Clostridium botulinum. Sockeye Suzys Fish LLC
Food Smoked Garlic Steelhead, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67362 6 Any production codes starting with OC. The last date of distribution of recalled products was September 2015. Class II Product has the potential to be contaminated with Clostridium botulinum. Sockeye Suzys Fish LLC
Food Smoked Jalapeno Chinook (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67312 1 Any production codes starting with OC. The last date of distribution of recalled products was September 2015. Class II Product has the potential to be contaminated with Clostridium botulinum. Sockeye Suzys Fish LLC
Food Smoked Jalapeno Spring Chinook (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67392 3 Any production codes starting with OC. The last date of distribution of recalled products was September 2015. Class II Product has the potential to be contaminated with Clostridium botulinum. Sockeye Suzys Fish LLC
Food Smoked Jalapeno Sturgeon, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67272 8 Any production codes starting with OC. The last date of distribution of recalled products was September 2015. Class II Product has the potential to be contaminated with Clostridium botulinum. Sockeye Suzys Fish LLC
Food Smoked Jalapeno Steelhead, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67352 7 Any production codes starting with OC. The last date of distribution of recalled products was September 2015. Class II Product has the potential to be contaminated with Clostridium botulinum. Sockeye Suzys Fish LLC
Food Smoked Sockeye, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67242 1 Any production codes starting with OC. The last date of distribution of recalled products was September 2015. Class II Product has the potential to be contaminated with Clostridium botulinum. Sockeye Suzys Fish LLC
Food Smoked Spring Chinook, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67402 9, UPC 7 48252 67382 4, UPC 7 48252 67372 5 Any production codes starting with OC. The last date of distribution of recalled products was September 2015. Class II Product has the potential to be contaminated with Clostridium botulinum. Sockeye Suzys Fish LLC
Food Smoked Steelhead, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67342 8 Any production codes starting with OC. The last date of distribution of recalled products was September 2015. Class II Product has the potential to be contaminated with Clostridium botulinum. Sockeye Suzys Fish LLC
Food Smoked Sturgeon, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67262 9 Any production codes starting with OC. The last date of distribution of recalled products was September 2015. Class II Product has the potential to be contaminated with Clostridium botulinum. Sockeye Suzys Fish LLC
Food Smoked Walleye, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 94504 39610 2 Any production codes starting with OC. The last date of distribution of recalled products was September 2015. Class II Product has the potential to be contaminated with Clostridium botulinum. Sockeye Suzys Fish LLC
Devices VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents. Software Version 3.2 and below; Serial Numbers J36000012 - 36000879 Class II Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. When this intermittent issue occurs, the VITROS Systems continue to operate and process results without notification to the User, possibly producing erroneous results. Ortho-Clinical Diagnostics
Devices VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750009916, Software Product Code 6802864, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents. Software Version 3.2 and below; Serial Numbers J56000024 - J56002309 Class II Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. When this intermittent issue occurs, the VITROS Systems continue to operate and process results without notification to the User, possibly producing erroneous results. Ortho-Clinical Diagnostics
Devices VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343, Software Version 3.2 and below; IVD. Product Usage: The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.) Software Version 3.2 and below; Serial Numbers J46001001 -J4600636 Class II Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. When this intermittent issue occurs, the VITROS Systems continue to operate and process results without notification to the User, possibly producing erroneous results. Ortho-Clinical Diagnostics
Devices VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Unique Device Identifier Number 10758750001644, Software Version 2.8 and below, IVD. Product Usage: The VITROS 5,1 FS Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.). Software Version 2.8 and below; VITROS 5,1 FS Chemistry System Serial Numbers J34000016 - J34002323; VITROS 5,1 FS Chemistry System Refurbished Serial Numbers 34000133, 34000193, 34000197, 34000212, 34000285, 34000316, 34000318, 34000337, 34000360, 34000420, 34000451, 34000478, 34000495, 34000497, 34000529, 34000538, 34000552, 34000557, 34000590, 34000596, 34000601, 34000631, 34000642, 34000761, 34000799, 34000805, 34000833,  ...
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Class II Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. When this intermittent issue occurs, the VITROS Systems continue to operate and process results without notification to the User, possibly producing erroneous results. Ortho-Clinical Diagnostics
Biologics Red Blood Cells, Leukocytes Reduced, Irradiated W202915180232; W202915236628 Class III Blood products, collected in a manner that may have compromised the sterility of the products, were distributed. American Natl Red Cross Mid Atlantic Region
Biologics Red Blood Cells, Leukocytes Reduced W202915179317; W202915179320; W202915179323; W202915179329; W202915199493; W202915199499; W202915237503; W202915237518; W202915237530; W202915237533; W202915180228; W202915180235; W202915225510; W202915225515; W202915225518; W202915237338; W202915237342; W202915237345; W202915237362; W202915237373; W202915180290; W202915180292; W202915180301; W202915180311; W202915180319; W202915225246; W202915225255; W202915195749; W202915195753; W202915225371; W202915225376; W202915225380; W202915225387; W202915225390; W202915180385; W202915180392; W202915225422; W202915225433; W202915225436; W202915225448; W202915225460; W2029152254710; W202915225476; W202915236623; W202915236629; W202915225984; W202915225986; W202915225988; W202915225991; W202915225994;  ...
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Class III Blood products, collected in a manner that may have compromised the sterility of the products, were distributed. American Natl Red Cross Mid Atlantic Region
Biologics Plasma Frozen within 24 hours (FP24) W202915179317; W202915179329; W202915199493; W202915237533; W202915180228; W202915225510; W202915225515; W202915237342; W202915237345; W202915237362; W202915180311; W202915225246; W202915225255; W202915225376; W202915225380; W202915225387; W202915225390; W202915180385; W202915180392; W202915225436; W202915225448; W202915225471; W202915225476; W202915236629; W202915225984; W202915225986; W202915225991; W202915226648; W202915226667; W202915226676; W202915226049; W2029151733100; W202915179335; W202915195771 Class III Blood products, collected in a manner that may have compromised the sterility of the products, were distributed. American Natl Red Cross Mid Atlantic Region
Biologics Red Blood Cells 2304073 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Blood and Blood Products for Reprocessing 2304073 Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Cryoprecipitated AHF W051715625538 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Rhode Island Blood Center
Biologics Plasma Frozen, Cryoprecipitated Reduced W051715625538 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Rhode Island Blood Center
Biologics Plasma Frozen within 24 hours (FP24) W20061564823100 Class III Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed. American National Red Cross The
Biologics Red Blood Cells, (Apheresis) Leukocytes Reduced W036515299461 (double collection) Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. LifeShare Blood Centers
Biologics Source Plasma TT0515102; TT0516347 Class II Blood products, collected from an unsuitable donor, were distributed. BPL Plasma, Inc.
Devices Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator Model 106 Serial numbers 36602, 37019, 39097, 40311, 40465 Class II Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit the potential for decreased battery longevity. Cyberonics, Inc
Devices NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set A disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis. Compatible for use with Fresenius 2008H, 2008K/K2 and 2008T dialysis machines. Lot #'s 13E02, 13E03, 13E06, 13E07, 13E08,13E09, 13E10, 13G03, 13G11, 13G15, 14G24, 13G30, and 13H06. Class II Blood foaming was found during evaluation of the product. Nipro Medical Corporation
Food Mi Tienda Masa Preparada By the Pound packaged in bag Sell by 11/16/15; UPC 22854300000 Class II Possible presence of metal fragments. HEB Retail Support Center
Food Mi Tienda Tostada Siveria Large Tostada packaged in bag Sell by 11/16/15 and 11/17/15; UPC 22859400000 Class II Possible presence of metal fragments. HEB Retail Support Center
Food Mi Tienda Tostaditas Botoneras Rojas packaged in bag Sell by 11/16/15 and 11/17/15; UPC 22847000000 Class II Possible presence of metal fragments. HEB Retail Support Center
Biologics Red Blood Cells W022115001139; Class II Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. Dept. of the Navy - U.S. Naval Hospital
Food Pasteurized Donor Human Milk, Frozen then thawed. Product is packaged in 4 oz. glass bottle with metal lid and plastic seal. A bar code is present on each label but there is NO UPC codes. Batch number 001757-1. Expiration date: 04/04/2016 The number reflects the pool of donor milk created (001757) and the single batch created from the pool(001757-1) Class II Report by recipient hospital found a foreign particle in a single bottle of mother's milk once thawed and opened. Finder reported the particle was a fruit fly or sugar ant. Northwest Mothers Milk Bank
Biologics Apheresis Red Blood Cells, Leukocytes Reduced W091015269516 (double collection) Class II Blood products collected using equipment that had not been validated, were distributed. Oklahoma Blood Institute - Sylvan N Goldman Center
Biologics Red Blood Cells, Leukocytes Reduced W045115149859; W045115149897; W045115148686; W045115149856; W045115152267; W045115143105; W045115143671; W045115145972; W045115149880; W045115139004; W045115153016; W045115153019; W045115153030 Class II Blood products, possibly contaminated with air, were distributed. Community Blood Center of the Ozarks
Biologics Platelets W035215263152Y Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed Carter BloodCare
Biologics Red Blood Cells, Leukocytes Reduced W270115521421 Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Central Pennsylvania Blood Bank
Biologics Plasma Frozen W270115521421 Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Central Pennsylvania Blood Bank
Biologics Pooled Platelets, Leukocytes Reduced W270115520076 Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Central Pennsylvania Blood Bank
Devices 0 deg, 8mm Endoscope, IS4000: Model numbers: 470026-34, 470026-40, 470026-41. General and Plastic Surgery: The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on the Surgeon Console 3D viewer and Vision Cart touchscreen. Endoscopes are available with either a 0 degree or 30 degree tips. Model numbers: 470026-34, 470026-40, 470026-41. All lots, Class II This correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 mm Endoscopes in combination with the da Vinci 8 mm and 12 mm cannulae, cannula reducers, and monopolar energy instruments. It informs customers of scenarios that may result in unintended patient harm due to capacitive coupling from monopolar energy sources. Intuitive Surgical, Inc.
Devices 30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41. General and Plastic Surgery: The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on the Surgeon Console 3D viewer and Vision Cart touchscreen. Endoscopes are available with either a 0 degree or 30 degree tips. Model numbers: 470027-34, 470027-40, 470027-41. All lots. Class II This correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 mm Endoscopes in combination with the da Vinci 8 mm and 12 mm cannulae, cannula reducers, and monopolar energy instruments. It informs customers of scenarios that may result in unintended patient harm due to capacitive coupling from monopolar energy sources. Intuitive Surgical, Inc.
Biologics Red Blood Cells, Leukocytes Reduced W270115514365 Class II Blood product, collected from a donor who traveled to a malarial endemic area, was distributed. Central Pennsylvania Blood Bank
Devices Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures. Lot Numbers: 1024313, 1024482, 1027160, 1034306, 1041879, 1059328 Class II There is cracking in the tray when the device is snapped into place. The crack is through the full thickness of the tray, compromising the sterile barrier. ArthroCare Corporation
Drugs Domperidone BP, Active Pharmaceutical Ingredient for Prescription Compounding, packaged in a) 5 gm (NDC: 52372-0898-01), b) 25 gm (NDC: 52372-0898-02), c) 100 gm (NDC: 52372-0898-03), and d) 500 gm (NDC: 52372-0898-04), Cas No. 57808-66-9, Rx only, FREEDOM, 801 W. New Orleans St., Broken Arrow, OK 74011. Lot #: F10349, F10349A, F10349B, F10349C, F10349D, F10349E, Exp 01/15; F10829, F10829A, F10829B, F10829C, F10829-2, F10829-2A, F10829-2B, F10829-2D, F10829-2E, F10829-3, F10829-3A, F10829-3B, F10829-3C, F10829-3D, Exp 01/17; F11035, F11035A, F11035B, F11035C, Exp 08/17 Class II Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin. Freedom Pharmaceuticals Inc
Devices RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms Brain Metastases version 1.0.0 Model/catalogue number Description 21702-04 ELEMENTS AUT. BRAIN METASTASES PLAN INST 21703-01 ELEMENTS ADAPT HYB  ...
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Class II Large objects with fine resolution are potentially displayed cropped when imported into Brainlab Brain Metastases 1.0.0. Brainlab AG
Devices RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms Adaptive Hybrid Surgery Analysis version 1.0.0 Model/catalogue number Description 21702-04  ...
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Class II Large objects with fine resolution are potentially displayed cropped when imported into Adaptive Hybrid Surgery Analysis version 1.0.0 Brainlab AG
Devices Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples Serial Numbers: DG06106539 DG12118720 DG07106646 DG12107250 DG12107281 DG03117619 DG11118605 DG01117400 DG12107202 DG01117401 DG06106449 DG03117666 DG05117791 DG06106454 DG03106180 DG11118637 DG07118121 DG07106598 DG11118633 DG06106520 DG03106137 DG07118111 DG02128888 DG08118247 DG06118014 DG01128790 DG12107207 DG07106637 DG01128876 DG04117764 DG01106035 DG12118780 DG05106342 DG01117399 DG06117909 DG06118011 DG09106846 DG11107146 DG12118694 DG08118217 DG02106084 DG04117690 DG05117838 DG09106799 DG04117735 DG03117548 DG01117362 Class II The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results. Perkinelmer
Devices Perkin Elmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples Serial Numbers: DG02117524 DG09118363 DG08118156 DG08118195 DG02128922 DG10118375 DG12107235 DG08118222 DG02117537 DG08118184 DG09106872 DG11107116 DG03117626 DG03117611 DG01117425 DG12107293 DG09118332 DG06106503 DG06118006 DG01128820 DG12118707 DG05106427 DG03106166 DG11118630 DG01117434 DG09106779 DG02117500 DG12118742 DG06106477 DG03106208 DG09106800 DG10106903 DG05117853 DG03117671 DG06106473 DG04117754 DG04117698 DG11118538 DG11118617 DG01117392 DG03117644 DG05117882 DG03117655 DG04117683 DG02106106 DG05106347 DG06118043 DG10118385 DG08106671 DG01128869 DG06118023 DG05106328 DG02117516 DG11107142 DG05106354 DG08118254 DG03106181 DG03106197 DG02117505 DG11107105 Class II The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results. Perkinelmer
Devices Perkin Elmer WIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050. The Wizard2 gamma counter is intended to detect and count gamma radiation emitted by clinical samples. Model: 2470-0050 Serial Numbers: DG05106329 DG02117493 DG11107166 DG09106782 DG07118133 DG07118141 DG09106791 DG04117727 DG06118036 DG12107192 DG02106101 DG04106223 DG01128843 DG12107272 DG07118124 DG09106892 DG12118684 DG12118673 DG11107126 DG04117704 DG04117763 DG01117363 DG06106484 DG12107240 DG01128871 DG05117880 DG12118685 DG09118357 DG03106204 DG05106386 DG11107137 DG03106172 DG03106206 DG02106113 DG09106818 DG02106065 DG04106309 DG09106882 DG11118590 DG06106483 DG01117316 DG08118221 DG06117898 DG12107263 DG08118250 DG12118711 DG04117710 DG06106448 DG06106453 DG06106463 DG06117912 DG03106135 DG01117373 DG05117837 DG06106517 DG01128805 DG06117970 DG04106310 DG02117521 DG06106538 Model: 3470-0050 (2 units) Serial Numbers: DG12118660 DG10118464 Class II The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results. Perkinelmer
Devices Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100. The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples Model Number: 2470-0100 Serial Numbers: DG06106436 DG08118240 DG02106050 DG06106502 DG11118609 DG01128795 DG02117461 DG12118702 DG09106861 DG05117833 DG05117834 DG10107006 DG06106452 DG09118367 DG03106154 DG04129081 DG06106559 DG06117903 DG07106599 DG09106774 DG05106387 DG06106524 DG10106949 DG09118284 DG05117787 DG04117755 DG09106770 DG03106196 DG04129159 DG08118192 DG06106469 DG08118189 DG04129075 DG12107252 DG12118677 DG06117923 DG08106741 DG03106186 DG12118759 DG01117444 DG02106112 DG12107236 DG11107031 DG12107249 DG11118612 DG05117781 Model: 3470-0100 (1 unit) Serial Number: DG02128911 Class II The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results. Perkinelmer
Devices Perkin Elmer WIZARD2 5-detector, 1000 samples Product Code: 2470-0150, 3470-0150 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples Serial Numbers: DG04129084 DG12118776 DG04117773 DG05106408 Class II The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results. Perkinelmer
Devices Perkin Elmer WIZARD2 10-detector, 1000 samples. Product Code: 2470-0200, 3470-0200. The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples Serial Numbes: DG08118243 DG12118732 DG09106871 DG03117554 DG05106373 DG02117481 DG11107153 DG07118106 DG03128981 DG04106316 DG03117574 DG04106296 DG04117674 DG05106414 DG02117455 DG07106607 DG11107048 DG03106163 DG07106604 DG05117805 DG08106759 DG03129008 Class II The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results. Perkinelmer
Devices Perkin Elmer WIZARD2 1-detector, 3", 1000 samples. Product Code: 2480-0010 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples Serial Numbers: DG12107256 DG04106256 DG08118161 DG03117633 DG09118348 DG06117938 DG04106271 DG03117625 DG11118603 DG03129003 DG11107087 DG09118269 DG09118346 DG09118323 DG09118410 DG10118462 DG12118695 DG03129030 DG05117802 DG04129089 DG11107086 DG03117631 DG10118453 DG01117421 DG04106256_REWORK DG06106456 DG03106146 DG11118564 DG03129000 DG02106095 DG08106711 DG02128912 DG10106940 DG07118046 DG07118051 DG03117635 DG09118273 DG05117890 DG12118657 DG09118349 DG03117557 DG10118483 DG10118478 DG11107160 DG04129156 DG02106081 DG09118167 DG02128958 DG03129032 DG03117634 DG11118575 DG08118256 DG05106334 DG10106910 DG10106950 DG03117630 DG05106409 DG07106656 DG12107176 DG05106333 DG05117810 DG10106978 DG03106122 DG12107186 DG08106662 DG05117817 DG05117874 DG02128962 DG11118610 DG03129033 DG03129034 DG12118735 DG11107053 DG09118307 DG07118070 DG09118306 DG08118170 DG02128953 DG02128936 DG03129053 DG08118162 DG11118587 DG03129031 DG02128933 DG03129002 DG03129001 DG08118163 DG02128895 DG10118489 DG02117474 DG09118281 DG09118316 DG10106976 DG06117966 DG06106504 DG08118168 DG08118169 DG11118545 DG01128861 DG10118448 DG10118458 DG10118474 DG10118458 DG10118472 DG01128794 DG03129055 DG09118321 DG07118071 DG10118440 DG02128879 DG03117632 DG10118408 DG02128927 DG06106505 DG10118418 DG01128802 DG12118717 DG12118769 DG12118783 DG01106026 DG09106876 DG03129068 DG05106332 DG01105987 DG03106128 DG10118388 DG08118165 DG01128850 DG06117937 DG06117936 DG06117939 DG08118166 DG04117759 DG11118579 DG10118424 DG01128854 DG01128856 DG12107271 DG11118623 DG08118164 DG01128829 DG09118312 DG06117986 DG03106165 DG12118688 DG05117847 DG10118417 DG02128918 DG04106222 DG06106437 DG11118584 DG03117571 DG09118290 DG09106811 DG12107248 DG04106273 DG08106755 DG10106977 DG10106938 DG06117987 DG03106136 DG12118727 DG02128898 DG06106464 DG11107127 DG05106395 DG11107034 DG01128809 DG11118596 DG04129132 DG09106843 DG02117463 DG02106083 DG09118289 DG03117597 DG12107197 DG02117542 DG12118710 DG01128838 DG11118535 DG10118499 DG10118502 DG10118519 DG11118526 DG05117780 DG11118528 DG03117628 DG12118749 Class II The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results. Perkinelmer
Devices AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046. Orthopedic surgical instrument for use with Encore Shoulder prosthesis. 178881L05, 178881L06, 183345L03, 178881L09, 178881L10, 183345L05, 178881L11, 178881L12, 183345L06 Class II The trial shell mating feature on the broach is undersized. Encore Medical, Lp
Devices Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures. 50856405, 50857510, 50860994, 50866789, 50867921, 50869464, 50869465, 50871131, 50872965, 50878229, 50878230, 50878231, 50878232, 50881328, 50881393, 50881394, 50881395, 50881506, 50881511, 50881512, 50882753, 50886316, 50886467, 50886468, 50886469, 50888285, 50888286, 50888287, 50888288, 50888373, 50890483, 50890484, 50890485, 50892357, 50892358, 50892359, 50892360, 60000321, 60000322, 60000323, 60000692, 60000789, 60000790, 60000833, 60000834, 60000835 Class II The firm's investigation of the Medrad Intego indicates that the inner diameter of the saline tubing is out of specification and may result in the system failing to position the dose correctly during extraction, potentially leading to a low measurement of the extracted dose or to a higher dose being extracted. The occluded SAS tubing may impair the priming function and prompt an RP prime failed. Bayer Healthcare
Food Sweet Leaf Organic Raspberry Iced Tea, 16 oz glass bottle UPC: 6-51538-06703-6 Best By Dates: 6/30/16, 8/31/16, 10/31/16 Class II Product contains glass particles Nestle Waters North America
Food Sweet Leaf Organic Half and Half Lemonade Tea, 16 oz glass bottle UPC: 6-51538-06708-1 Best By Dates: 6/30/16, 8/31/16, 10/31/16 Class II Product contains glass particles Nestle Waters North America
Food Sweet Leaf Organic Original Sweet Tea, 16 oz glass bottle UPC: 6-51538-06700-5 Best By Dates: 6/30/16, 8/31/16, 10/31/16 Class II Product contains glass particles Nestle Waters North America
Food Sweet Leaf All Natural Citrus Green Tea, 16 oz glass bottle UPC: 6-51538-06720-3 Best By Dates: 6/30/16, 8/31/16,10/31/16 Class II Product contains glass particles Nestle Waters North America
Food Sweet Leaf All Natural Peach Iced Tea , 16 oz glass bottle UPC: 6-51538-06704-3 Best By Dates: 6/30/16, 8/31/16,10/31/16 Class II Product contains glass particles Nestle Waters North America
Food Sweet Leaf Organic Tea Mint & Honey, 16 oz glass bottle UPC: 6-51538-06701-2 Best By Dates: 6/30/16, 8/31/16, 10/31/16 Class II Product contains glass particles Nestle Waters North America
Devices Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant and construct of the Occipital-Cervical-Thoracic spine (Occiput-T3). UDI Number 889024328952 Lots: 62968065, 62947660, 62536230, 62745662, 62773482, 62758613, 62874869 Class II Zimmer Biomet is initiating a recall of the Virage Occipital Eyelet, as it was found through product testing that the staking of the set screw was out of specification and can interfere with the insertion of the occipital rod when the set screw is staked too low. Zimmer Biomet, Inc.
Food PICOSITO Jalapenos Distributed by: Sweet Superior Fruit LTD. CO. PRODUCE OF MEXICO LOT ORTI04 Class I Tested positive for Salmonella. Sweet Superior Ltd
Food Roasted Seasoned Himego Fish Product is packaged in a 240 KG cardboard master carton and individual fish fillets are further packaged in a clear plastic bag. C1013c and 01 Class III Snack Depot is recalling himego fish because it was mislabeled and misidentified. SNACK DEPOT, INC.
Food Roasted Seasoned Himego Fish (spicy) Product is packaged in a 240 KG cardboard master carton and individual fish fillets are further packaged in a clear plastic bag. C1013h and 02 Class III Snack Depot is recalling himego fish because it was mislabeled and misidentified. SNACK DEPOT, INC.
Devices Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary Serial numbers 702961, 702963, 705644, 705666, and 705947. Class II The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker. Boston Scientific Corporation
Devices Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary. Serial numbers 209409, 209518, and 209609. Class II The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker. Boston Scientific Corporation
Drugs HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton, Rx only, Packaged and Distributed by American Health Packaging Columbus, Ohio 43217, NDC 68084-0398-01 Lot # 151379 and Lot #151380; Exp 12/16 Class II Presence of Particulate Matter Amerisource Health Services
Devices MOVES System, an emergency ventilator with suction, oxygen concentrator and multi-parameter patient monitoring capabilities. The MOVES System is a portable computer controlled electrically powered transport emergency ventilator intended to provide continuous or intermittent ventilatory support for the care of adults who require ventilation. MS201205001, MS201205002, MS201205003, MS201205004, MS201205005, MS201212001, MS201212002, MS201212003, MS201212004, MS201212005, MS201212006, MS201212007, MS201212008, MS201212009, MS201212010, MS201212011, MS201212012, MS201212013, MS201212024, MS201212025, MS201212026, MS201212028, MS201212029, MS201212030, MS201212031, MS201212032, MS201212033, MS201212034, MS201212035, MS201212036, MS201212037, MS201212038, MS201212039, MS201212040, MS201212041, MS201212042, MS201212053, MS201212054, MS201212055, MS201212056, MS201212057, MS201212058, MS201212059, MS201212060, MS201212061, MS201212062, MS201212062, MS201212063, MS201212064, MS201212065,  ...
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Class I Batteries found unresponsive after storage, not recognized by main device, and are perpetually enabled. Thornhill Research Inc
Devices MOVES System Lithium Polymer Batteries The MOVES System is a portable computer controlled electrically powered transport emergency ventilator intended to provide continuous or intermittent ventilatory support for the care of adults who require ventilation. MB201205001, MB201205002, MB201205003, MB201205004, MB201205005, MB201205006, MB201205007, MB201205008, MB201205009, MB201205010, MB201208001, MB201208002, MB201208003, MB201208004, MB201212001, MB201212002, MB201212003, MB201212004, MB201212005, MB201212006, MB201212007, MB201212008, MB201212009, MB201212010, MB201212011, MB201212012, MB201208019, MB201208020, MB201308021, MB201308022, MB201308023, MB201308024, MB201308025, MB201308026, MB201308027, MB201308028, MB201308029, MB201308031, MB201308032, MB201308033, MB201308034, MB201308035, MB201308036, MB201308038, MB201308039, MB201308040, MB201308041, MB201308042, MB201308043, MB201308044,  ...
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Class I Batteries found unresponsive after storage, not recognized by main device, and are perpetually enabled. Thornhill Research Inc
Devices Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Model Numbers: 5921-218-135, 5921-044-135, 5921-034-135, 5921-034-235, 5921-024-236 Indicated for use in patients who require surgery of the extremities. Model #5921-218-135 Lot #3490521 Model #5921-034-235 Lot #3531111 Model #5921-034-135 Lot #3733336, 4002152 Model #5921-044-135 Lot #3759409 Model #5921-024-236 Lot #3822485 Class II Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single port when they contained dual port, and vice versa. Stryker Sustainability Solutions
Devices FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent. Lot No. 4162520, 4206855, 4267919, 4276818, 4309977, 5009530, 5036624, 5085573, 5182818 Class III Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) is exhibiting functional degradation. The functional degradation has the effect of reducing the percent positive from 100% down to approximately 87%. Becton, Dickinson and Company, BD Biosciences
Drugs Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each, 100 softgels per bottle. UPC 0-79854-95005-2 Manufactured and Distributed by: NATIONAL VITAMIN COMPANY Casa Grande, AZ 85122. NDC 54629-0640-01 Lot #: 5EA46, Exp 02/17 Class III Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg. National Vitamin Co Inc
Devices Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applications for viewing purposes and to provide an articulating point of movement on the ceiling mounted radial arm suspension system of the Ergon 2 equipment pendant / booms Model Number(s): H8-010-50-FC2-LH and H8-010-50-FC2-RH. VESA plates distributed from 09/26/08 to 04/30/13. Class II The hardware that holds the VESA plate and the display interface / monitor to the bracket may fail causing the display interface to fall from the bracket. Over time and with use the threaded rod hardware material can weaken and detach from the bracket. A display interface falling from its mounting location may result in injury to the patient or provider. Skytron, Div. The KMW Group, Inc
Devices Model NuCARTGN. The NuCART is a mobile display and image management platform used in Minimally Invasive Surgery (MIS) environments to facilitate the routing and ergonomic display of video signals from source devices to flat-panel monitors. It is tailored for use with an OEC C-arm and Endo-Cam in MIS surgery suites, Ambulatory Surgery Centers, Urology, GI and other suites. Lot# T9993-02-01 /15924CARTXXTNNA / DX00357 Lot# T9993-02-02 / 15924CARTXXAZPH / DX00358 Lot# U0328-02-02 / 15A01CARTXXCOEN /DX00360 Lot# U0328-02-01 / 15A26CARTXXCAK1 / DX00359 Lot# U0718-02-01 / 15A26CARTXXCAK2 / DX00361 Lot# U0718-02-02 / 15A26CARTXXCAK3 / DX00362 Lot# U1033-02-01 / 15A19CARTXXOHCA /DX00363 Lot# U1033-02-02 / 15A26CARTXXCASJ / DX00364 Lot# U1126-02-01 / 15A26CARTXXCAK41 /DX00365 Lot# U1126-02-02 / 15806CARTXXGAAT / DX00366 Class II The attachment of the NuCART Spring Arm to the NuCART horizontal boom may come apart if the securing ring (snap ring) was not installed correctly causing the spring arm to release and detach. CompView Medical, LLC
Food TWININGS OF London ENGLISH BREAKFAST BLACK TEA DECAFFEINATED, 12-0.11OZ (3.2g)/ EA NET WT 1.34 oz (38g), UPC 00070177513078 Lot #: 105657B- Best Before Date: 04/28/17 Class III Twinings English Breakfast Black Tea 12ct Kcups, were packaged in cartons stating Twinings English Breakfast Black Tea Decaffeinated. Twinings North America, Inc.
Devices iChem 10 SG Urine Chemistry Strips, PN 800-7005. Intended for the in vitro measurement of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color. 510033A, expiration 2015-03 510034A, expiration 2015-04 510035A, expiration 2015-07 510035B, expiration 2015-09 Class II Iris International is recalling the iChem 10 SG Urine Chemistry Strip because of false positive leukocyte result for samples that are truly negative. Beckman Coulter Inc.
Devices Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length; Zimmer Periarticular Locking Plate System 2.4mm Locking Screw 14 mm Length. Indicated for temporary internal fixation and stabilization of osteotomies and fractures. Item 00-2359-058-35, Lot 62918019 PERI LOCKING SCREW 3.5MM Item 00-2359-014-24, Lot 62896038 PERI LOCKING SCREW 2.4MM Class II Product on the package label did not match what was inside the package. The label was for part number 00-2359-058-35 (Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58mm Length) lot number 62918019 while the product inside the package was part number 00-2359-014-24 (Zimmer Periarticular Locking Plate System 2.4mm Locking Screw 14mm Length) lot number 62896038. Zimmer Biomet, Inc.
Devices Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11 Holes 144mm Length Zimmer Universal Locking System 3.5mm Locking Dual Compression Plate 8 Holes 105mm Length. Indicated for temporary internal fixation and stabilization of osteotomies and fractures. Part 00-4936-011-13, Lot 62968956 3.5MM ULS RECON PLATE 11H Part 00-4936-008-07, Lot 62968974 3.5MM ULS DUAL COMP PLT 8 Class II The product on the package label did not match what was inside the package. The label was for part number 00-4936-011-13 lot number 62968956 while the product inside the package was part number 00-4936-008-07 lot number 62968974. Zimmer Biomet, Inc.
Devices UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. Item number; lot; product description 00-1300-1735; 44003; 5.5/6.0 UNIAXIAL REDUCTION PEDICLE  ...
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Class II Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured incorrectly, thus preventing the driver from fully engaging into the hexagonal drive feature of the screw. OrthoPediatrics Corp
Drugs DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0972-02, UPC 3 0555-0972-02 0. Lot #: 34015516A, Exp 05/16 Class II Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing. Teva Pharmaceuticals USA
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