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U.S. Department of Health and Human Services

Enforcement Report - Week of April 1, 2015

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Source Plasma 3330027146, 3330027592, 3330026760, 3330027107, 3330028802, 3330030243, 3330027132, 3330027580, 3330028188, 3330027405, 3330028931, 3330001198, 3330030226, 3330028269, 3330027846, 3330001992, 3330001298, 3330029306, 3330028645, 3330028427, 3330028860, 3330029539, 3330026753, 3330027121, 3330027736, 3330028946, 3330017740, 3330018107, 3330018653, 3330021666, 3330031442, 3330030797, 3330027185, 3330026988, 3330020104, 3330019772, 3330018314, 3330017911, 3330018797, 3330020388, 3330020522, 3330021207, 3330022104, 3330018294, 3330030630, 3330029898, 3330029224, 3330028737, 3330028086, 3330027616,  ...
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Class II Blood products, collected from donors who did not receive a complete physical examination, were distributed. Talecris Plasma Resources, Inc.
Biologics Plasma Frozen within 24 hours (FP24) 022FQ88154, 022LM01802, 022FY85675, 022GH86209, 022GZ42854, 022FL11167, 022GC23202, 022LP63095, 022FQ88122, 022FZ77043, 022LM01798, 022FZ82868, 022GC19391, 022GG44948, 022GH86311, 022GL83755, 022GT34144, 022KE81309, 022LP65162, 022FC82917, 022FP18504, 022FQ87357, 022GP32826, 022LP60594, 022FG80187, 022GC23210, 022GT38940, 022FL08882, 022GC23600, 022GP37894, 022FC82212, 022GK39324, 022GC19502, 022GC22499, 022GC21704, 022FQ87869, 022FX83237, 022GL82484, 022GV37970, 022FL08826, 022FQ82066, 022FX83016, 022FY85673, 022FY85681, 022GC19495, 022GC19504, 022GC25323, 022GG44921, 022GG44942, 022GG44954,  ...
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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 022GC25203, 022GS70886, 022GC26283, 022FQ87176, 022FZ84335, 022GJ28831, 022GY42916, 022GG50556, 022LP60846, 022LM01668, 022GG50974, 022GH85213, 022LP63685, 022FQ84675, 022GS70935, 022FQ87315, 022GS70882, 022GH78461, 022GY42754, 022GM67934, 022GS70640, 022FS95911, 022GL83742, 022GY42943, 022GC26238, 022GC26246, 022GY42725, 022LP65144, 022GL83026, 022GL83896, 022GJ27924, 022GZ42749, 022LX29819, 022GY42747, 022GY39694, 022KE78629, 022LX30237 (3 units), 022GG50978, 022GS65484, 022GG50931, 022GS70642, 022GY42957, 022FY85437, 022GC23633, 022GH78463, 022GH86225, 022GJ27274, 022GL83070,  ...
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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 022GV44331, 022FP18489, 022FL11156, 022GC26246, 022FL11167, 022GC26238, 022GS70935, 022LM01779, 022GS70886, 022GV44412, 022GS70635, 022GC26124, 022GG50978, 022FL11132, 022GC26259, 022FP18492, 022GC26263, 022GC26283, 022LM01681, 022LM01763, 022FP18502, 022GC26288, 022GC26147, 022GS70917, 022LX31505, 022GP37929, 022GG50553, 022FP18487, 022FL11161, 022GY42754, 022FY89578, 022GC26140, 022GG50936, 022LC76611, 022FP18504, 022FY89574, 022LC76608, 022LX31513, 022GP37894, 022FY89572, 022FY89575, 022GP37907, 022GY42714, 022GP37910, 022GP37925, 022FY89573, 022GJ28831, 022FS95934, 022GY42712, 022LC76601,  ...
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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 Pooled Leukocytes Reduced 022LF20406, 022LF20495, 022LF20498, 022LF20532, 022LF20537, 022LF20547, 022LF20548, 022LF20704 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 022GC26249 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 022LM01652, 022LM01667, 022LM01668, 022LM01706, 022LM01708, 022GJ27919, 022LX32766 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American National Red Cross (The)
Devices Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Number: 9065 and 9067. These rechargeable batteries are used to supply power to the following products: Wireless ECG Module used with the Precess MRI compatible Patient Monitoring System, Wireless SpO2 Module used with the Precess MRI Compatible Patient Monitoring System, Philips Basic Triggering Set, Philips Monitoring Sensor Set, Philips Battery Set Batteries with date codes 2808 or earlier. Class II VCG battery ignited in a VCG unit when recharging. Philips Medical Systems, Inc.
Food Mini Naan Eight (8) nann packaged in coated paper printed board and transparent wrap with a net weight of 12.6 oz (360 g) per package and old under the US Foods brand. Product is labeled with instructions to keep frozen until use. Eight (8) packages per case. Production codes: 14037, 14045, 14051, 14231, 14247, 14254, 14268. Class II The products were shipped without labels declaring the nutrition and ingredients information and the presence of egg, milk, and wheat allergens. fgf brands, inc
Drugs Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American Specialty Pharmacy, Plano, TX 75075 214-919-2090. NDC 99999-9994-27 Lot# 10082014@10 Class II Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product American Specialty Pharmacy
Devices Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining. Product Usage: NCL-L-CD15 is intended for the qualitative identification by light microscopy of CD15 molecules in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patients clinical history and other diagnostic tests by a qualified pathologist. Product Code: NCL-L-CD15; Lot Numbers and Expiration Dates: Lot 6022274, Expiry 2015-04; Lot 6024628, Expiry 2015-08; Lot 6030581, Expiry 2016-07 Class II The staining intensity decreases over the shelf life. Leica Microsystems, Inc.
Drugs B-Lipo, 30 Capsules, Manufactured by KM DALI, Kunming, China for Bethel Nutritional Consulting, Inc.599 West 190th Street, Suite #1 NYC, NY 10040. Lot #: 20213, Exp 12/22/2016. Class II Marketed without an Approved NDA/ANDA; found to contain Lorcaserin, a controlled substance used for weight loss Bethel Nutritional Consulting, Inc
Food Guava filled pastry ("Pastelillo de Guayaba" in Spanish) 2.5 oz and 10 oz. 16333 31 030 Class II Ingredients in label for "Pastelillos de Guayaba" (Guava Pastries) do not include soy lecithin. Vitony Bakery, Inc.
Devices Penner Patient Stretcher/Transfer Lift System Models 391000-1 and 392000-1 The Pacific Stretcher/Transfer Lift is used with Whirlpool or Aqua-Aire (air bubbling) bathing system intended for use in nursing homes, hospitals, and assisted living facilities to transfer and/or lift patients under the direct supervision of trained staff. Model 392000-1 is equipped with a scale. Serial numbers: 01050741201, 01071198001, 01071198002, 01071198003, 01071198004, 01091136401, 01091136402, 01091136403, 01101314201, 01101322801, 01111505901, 02071228401, 02071228402, 02071228403, 02071228404, 02080975001, 02080975002, 02091137801, 02091149801, 02121713401, 03050791101, 03050804301, 03050804302, 03050804303, 03050804304, 03050804305, 03050804306, 03071247201, 03071247202, 03071247203, 03071247204, 03080984601, 03080984602, 03080984603, 03091161601, 03101347201, 03121742801, 03122862901, 04040581301, 04040581302, 04040581303, 04040581304, 04040581305, 04040581306, 04040581307, 04040581308, 04040581310, 04040581311,  ...
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Class II If the patient sits on either wing, not squarely on the center section of the Stretcher Lift, tipping and injury to the operator or patient could result. The device manual was updated with an additional warning statement. Penner Mfg Inc
Food Ground Cumin, sold under Aunt Patty's brand, packed in 1lb. pack, 5 lb. pack, 25 lb. pack, and 50 lb. pack. Product is labeled in part, "***Handled in a facility that processes and/or repacks peanuts, soy, wheat, tree nuts, and dairy products.***" Item #12650 is for 1 lb. Item #12648 is for 5 lb. Item #12651 is for 25 lb. Item #12649 is for 50 lb. Lot code for 1 lb. pack: MG0074013; Lot codes for 5 lb. pack: MG0076070, MG0078195, AND MG0074282; Lot codes for 25 lb. pack: MG0076503, MG0077469, AND MG0073506; Lot codes for 50 lb. pack: MG0076762 AND MG0073750; Class I Ground Cumin is recalled because it contains more than 25 ppm of peanut protein. GloryBee Inc
Food Barley & Lentil Soup Spice Mix, sold under Aunt Patty's brand, packaged in 25 lb. pack. Item # 18058. Product is labeled in part, "***Handled in a facility that processes and/or repacks peanuts, soy, wheat, tree nuts, and dairy products.***" MG0074435 Class I Barley & Lentil Soup Spice Mix is recalled because it may contain traces of peanut protein. GloryBee Inc
Food Mild Chili Powder, Salt-Free, sold under brand Aunt Patty's brand, packaged in 25 lb. pack. Item #14835. Product is labeled in part, "***Handled in a facility that processes and/or repacks peanuts, soy, wheat, tree nuts, and dairy products.***" MG0074441 Class I Mild Chili Powder Salt Free is recalled because it contains more than 25 ppm peanut protein. GloryBee Inc
Devices Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425 Lot No. 68965-1241 Class II Advanced Sterilization Products (ASP) is recalling the Tyvek Rolls with STERRAD Chemical Indicator because they were shipped to customers after its expiration date of May 18, 2013. Advanced Sterilization Products
Food HEB Bean & Cheese Dip 9 oz. UPC: 041220804016 Lot# SA14321 Expiration: 11/17/2016; Lot# SA14346 Expiration: 12/12/2016; Lot# SA14338 Expiration: 12/03/2016 Class II Undeclared Peanuts. Dursett Amigos, Ltd
Food HyVee Taco Dinner Kit 12 hard shells, taco sauce & seasoning mix; Net Wt. 9.75 oz. (276 g); UPC:075450018073; DISTRIBUTED BY HY-VEE, INC. 5820 WESTOWN PARKWAY WEST DES MOINES, IA 50266 Lot# 060115 Class II Undeclared Peanuts. Dursett Amigos, Ltd
Food Laura Lynn Taco Dinner Kit Kit Includes: 12 Taco Shells,Seasoning Mix Salsa; Net Wt. 9.75 oz. (276 g); UPC:086854045923; DISTRIBUTED BY INGLES MARKETS, INC. ASHEVILLE, NC 28816 Lot# 060915 Class II Undeclared Peanuts. Dursett Amigos, Ltd
Food Parade Taco Dinner Kit Includes Shells, Seasoning and Sauce Net Wt. 9.75 oz. (276 g); UPC:050700091518; DISTRIBUTED BY FEDERATED GROUP, INC. 3025 W. SALT CREEK LN. ARLINGTON HEIGHTS, IL 60005 Lot# 061415 Class II Undeclared Peanuts. Dursett Amigos, Ltd
Food HyVee Taco Sauce Medium Net Wt. 16 oz. (454 g); UPC:075450018196; DISTRIBUTED BY HY-VEE, INC. 5820 WESTOWN PARKWAY WEST DES MOINES, IA 50266 Lot# SA14317 Class II Undeclared Peanuts. Dursett Amigos, Ltd
Food HyVee Taco Sauce Mild Net Wt. 16 oz. (454 g); UPC:075450018219; DISTRIBUTED BY HY-VEE, INC. 5820 WESTOWN PARKWAY WEST DES MOINES, IA 50266 Lot# SA14317 Class II Undeclared Peanuts. Dursett Amigos, Ltd
Food HyVee Enchilada Sauce Mild Net Wt. 15 oz. (425 g); UPC:075450018097; DISTRIBUTED BY HY-VEE, INC. 5820 WESTOWN PARKWAY WEST DES MOINES, IA 50266 Lot# SA14325 Class II Undeclared Peanuts. Dursett Amigos, Ltd
Food Brookshire's red Enchilada Sauce Net Wt. 15 oz. (1 LB) 425g; UPC:092825097488; DISTRIBUTED BY: BROOKSHIRE GROCERY COMPANY P.O. BOX 1411,TYLER, TX 75710-1411 Lot# SA14325 Class II Undeclared Peanuts. Dursett Amigos, Ltd
Food Roundy's original enchilada sauce Net Wt. 15 oz. (425 g); UPC:011150083492; DISTRIBUTED BY: ROUNDY'S SUPERMARKETS, INC. MILWAUKEE, WI 53201-0473 Lot# SA14325 Class II Undeclared Peanuts. Dursett Amigos, Ltd
Food Ricos Thick 'N Chunky Salsa Net Wt. 132 oz. (3.74 Kg); UPC:079426650670; RICOS PRODUCTS CO., INC. 830 S PRESA ST SAN ANTONIO, TEXAS 78210 Lot# SA14322 Expiration: 05/17/2016, Lot# SA14329 Expiration: 05/24/2016; Lot# SA14343 Expiration: 06/07/2016 Class II Undeclared Peanuts. Dursett Amigos, Ltd
Food Roundy's Salsa Verde Salsa Net Wt. 16 oz. (1 LB) 454 g; UPC:011150083645; DISTRIBUTED BY ROUNDY'S SUPERMARKETS, INC. MILWAUKEE, WI 53201-0473 Lot# SA14330 Class II Undeclared Peanuts. Dursett Amigos, Ltd
Food Taj ETHNIC GOURMET BOMBAY CURRY Simmer Sauce, NET WT 16.0 OZ. (454.0g), UPC 7 18687 30010 7 BEST BY DATE: 15OCT16 Class II Cumin may contain undeclared peanut protein. The Hain Celestial Group- Worldwide Headquarters
Food Taj ETHNIC GOURMET CALCUTTA MASALA Simmer Sauce, NET WT 16.0 OZ. (454.0g), UPC 7 18687 30011 4 BEST BY DATE: 15OCT16 Class II Cumin may contain undeclared peanut protein. The Hain Celestial Group- Worldwide Headquarters
Food Taj ETHNIC GOURMET PUNJAB SAAG Spinach Sauce, NET WT 16.0 OZ. (454.0g), UPC 7 18687 30013 8 BEST BY DATE: 16OCT16 Class II Cumin may contain undeclared peanut protein. The Hain Celestial Group- Worldwide Headquarters
Devices Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of surgical procedures, including, but not limited to general orthopaedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngolical, reconstructive, and spine surgery. Part Number 05.001.012 Lot Numbers AV18166 AV19044 AV20666 Class II In May 2013, the original recall was initiated due to complaints the Hand Switch for the Electric Pen Drive was not labeled correctly, and the on and lock labels were interchanged. Synthes, Inc.
Food Reo Country Style Chili Seasoning NET WT 2 OZS (67G) Reo Spice & Seasoning, Inc. Huntsville, TX 77320 (936)294-0222; Reo Country Style Chili Seasoning NET WT 4 OZS(113G) Reo Spice & Seasoning, Inc. Huntsville, TX 77320 (936)294-0222; Reo Country Style Chili Seasoning NET WEIGHT ONE POUND Reo Spice & Seasoning, Inc. Huntsville, TX 77320 (936) 294-0222 Lot# 0925141 Class I Product may contain undeclared peanuts. Reo Spice & Seasoning, Inc
Food Ground Cumin Net Weight 5 LBS (2.27KG) Bryan, Texas 77802 Distributed by: Ruffino Meats Food Service (979)776-5685 Lot# 2927e, 2948i Class I Product may contain undeclared peanuts. Reo Spice & Seasoning, Inc
Food Reo Bear Creek Kitchen Texas Chili Blend Net WT 25 lbs Reo Spice & Seasoning, Inc. Huntsville, TX 77320 (936)294-0222 Lot# 1205141, 1205142, and 1205143 Class I Product may contain undeclared peanuts. Reo Spice & Seasoning, Inc
Food Vitek's BBQ Seasoning Net Weight 25 LBS Manufactured By: Reo Spice & Seasoning, Inc. Huntsville, TX 77320 936-294-0222 Lot# 102814, 121814 Class I Product may contain undeclared peanuts. Reo Spice & Seasoning, Inc
Food Reo Ranch House Sizzling Steak Beef Jerky Seasoning Total Net Wt. 7.74 LBS Reo Spice & Seasoning, INC. Huntsville, TX 77320 (936)294-0222 Lot# 112114 Class I Product may contain undeclared peanuts. Reo Spice & Seasoning, Inc
Food Bon Ton Market BBQ Seasoning Net Wt 12 OZS (340 GRAMS) Manufactured for: Bon Ton Market Uhland, TX 78640-4909 (512)396-3810 Lot# 102114 Class I Product may contain undeclared peanuts. Reo Spice & Seasoning, Inc
Food Reo Texas Burger Taco Meat Mix NET WT. 40LBS Reo Spice & Seasoning, Inc. Huntsville, TX 77320 Lot# 100714, 1105141, and 1105142 Class I Product may contain undeclared peanuts. Reo Spice & Seasoning, Inc
Food Jmad's South Texas BBQ Seasonall net Wt 10 OZS (284G) Distributed by: Jmad's Seasonings Corpus Christi, TX 78414 (361)561-4111 Lot# 1030141 Class I Product may contain undeclared peanuts. Reo Spice & Seasoning, Inc
Food Jmad's Brisket Rub Net Wt 10 ozs (284g) Distributed by: Jmad's Seasonings Corpus Christi, TX 78414 (361)561-4111 Lot# 1105141 Class I Product may contain undeclared peanuts. Reo Spice & Seasoning, Inc
Biologics Cryoprecipitated AHF W128713182239 Class III Blood product, collected from a donor who tested reactive for the antibody to hepatitis B core antigen (anti-HBc) on two occasions, was distributed. Delta Blood Bank
Devices cobas® EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay T08661 Class III False positive results for Exon 20 insertion mutations are being detected with the cobas® EGFR Mutation Test, kit batch T08661. Roche Molecular Systems, Inc.
Food ALOHA VANILLA PREMIUM PROTEIN is a powder and product is packed as the following: 1) Tin: UPC 641061842606, 2) Pouch: UPC 641061842644 and 3) Protein Tower 14 pack: UPC 640864820729. Formulated, Quality Tested & Exclusively Sold by ALOHA, Inc. NY, NY 10011 +1 888.444.3898 All lot codes (GI-6940, GI-6967, GI-7009, GI-7039) Class II Aloha has recalled protein powder dietary supplements due to the presence of Staphylococcus enterotoxin Aloha
Food ALOHA CHOCOLATE PREMIUM PROTEIN is a powder and , product is packed as the following: 1) Tin: UPC 641061842613, 2) Pouch: UPC 641061842651 and 3) Protein Tower 14 pack: UPC 640864820743. Formulated, Quality Tested & Exclusively Sold by ALOHA, Inc. NY, NY 10011 +1 888.444.3898 All codes (GH-6934, GH-6981, GH-7008, GH-7038) Class II Aloha has recalled protein powder dietary supplements due to the presence of Staphylococcus enterotoxin Aloha
Food ALOHA VANILLA AND CHOCOLATE PREMIUM PROTEIN powders are distributed under the following labels: 1) ALOHA PREMIUM PROTEIN FREE TRIAL, 2) ALOHA PREMIUM PROTEIN 4 Pack, 3) ALOHA DAILY GOOD AND PREMIUM PROTEIN FREE TRIAL, 4) ALOHA SUPERFOOD SMOOTHIE KIT FREE TRIAL, 5) ALOHA SUPERFOOD SMOOTHIE KIT, 6) ALOHA THE FOUNDATION AND PREMIUM PROTEIN FREE TRIAL, 6) ALOHA DISCOVERY KIT and the 7) ALOHA URBAN OUTFITTERS SUPERFOOD SMOOTHIE KIT. Formulated, Quality Tested & Exclusively Sold by ALOHA, Inc. NY, NY 10011 +1 888.444.3898 All codes Class II Aloha has recalled protein powder dietary supplements due to the presence of Staphylococcus enterotoxin Aloha
Devices ADVIA® Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the calibration of Phenobarbital_2 (PHNB_2), Phenytoin_2 (PHNY_2), and Theophylline_2 (THEO_2) methods on the ADVIA Chemistry systems. System Information: (For Information Only) The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use. The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use. Material Number 10376770, Lot Number 3JD018, Expiration: April 2015 Class II Incorrect calibrator lot values were assigned for ADVIA® Chemistry Systems Drug Calibrator I, lot 3JD018, for the ADVIA Chemistry Systems Phenytoin 2 (PHNY_2) and Phenobarbital 2 (PHNB_2) assays which was the result of calibrator value miscalculation. Siemens Healthcare Diagnostics, Inc.
Devices GE Inspection Technologies x|tome|x L240 an Cabinet X-ray system SN - PA1260 Class II It was discovered that the upper left corner-shaped lead shield in the window in one of the doors of the v|tome|x L240 installed had lost adhesion and fall out of position, which could lead to gaps in shielding. GE Inspection Technologies, LP
Devices GE Inspection Technologies x|argos 160D system. Cabinet x-ray system. SN - PA1053 Class II It was discovered that the upper left corner-shaped lead shield in the window in one of the doors installed had lost adhesion and fall out of position, which could lead to gaps in shielding. GE Inspection Technologies, LP
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W051514107684; W051514107684; W051514039662; W051514039662; Class II Blood products, collected from a donor who visited a malarial endemic area, were distributed. Innovative Blood Resources
Biologics Red Blood Cells Leukocytes Reduced W051514086792; Class II Blood products, collected from a donor who visited a malarial endemic area, were distributed. Innovative Blood Resources
Biologics Red Blood Cells W051514040862; Class II Blood products, collected from a donor who visited a malarial endemic area, were distributed. Innovative Blood Resources
Biologics Red Blood Cells Leukocytes Reduced W051514105533; Class II Blood product, collected from a donor who visited a malarial endemic area, was distributed. Innovative Blood Resources
Biologics Red Blood Cells Leukocytes Reduced W051514096646; W051514029128; Class II Blood products, collected from a donor who visited a malarial endemic area, were distributed. Innovative Blood Resources
Biologics Red Blood Cells Leukocytes Reduced W051514109259; Class II Blood products, collected from a donor who visited a malarial endemic area, were distributed. Innovative Blood Resources
Biologics Red Blood Cells W051514084940; Class II Blood products, collected from a donor who visited a malarial endemic area, were distributed. Innovative Blood Resources
Biologics Red Blood Cells Leukocytes Reduced Irradiated W051514024000; Class II Blood products, collected from a donor who visited a malarial endemic area, were distributed. Innovative Blood Resources
Biologics Red Blood Cells Leukocytes Reduced W051514107355; W051514057671; W051513148482; Class II Blood products, collected from a donor who visited a malarial endemic area, were distributed. Innovative Blood Resources
Food Frozen vegetable-based burgers RETAIL - DOMESTIC: Organic Sunshine Burgers Gluten Free Soy Free Vegan Barbecue 3 Organic Veggie Burgers Keep Frozen Net WT: 8 OZ. Best Before: 5/4/16; 6/11/2016; 8/13/16; CANADIAN: Organic Sunshine Burgers Barbecue 3 Organic Veggie Burgers Galettes Veggie biologiques Keep Frozen/Garder Congale 3-75 g Burgers/galettes 227 g Best Before/meilleur avant: 16/05/2016 Retail: Item #000023 BBQ Flavor Best Before: 5/4/16, 6/11/2016, 8/13/16 Canadian: Item #010023 BBQ Flavor Best Before: 5/4/16 Class II Gluten testing was performed on products labeled gluten free. The results received back were >20ppm. Sunshine Burger & Specialty Food Company, LLC
Food Frozen vegetable-based burgers RETAIL - DOMESTIC: Organic Sunshine Burgers Gluten Free Soy Free Vegan South West 3 Organic Veggie Burgers Keep Frozen Net WT: 8 OZ. Use By: 7/13/16; 7/21/16; 7/28/16; 8/4/16; 8/11/16; FOOD SERVICE: Sunshine Southwestern Style Veggie Burgers 24 Veggie Burgers Net WT: 6 lbs. Item #001113 Use by: 7/13/16; 8/11/16 Retail: Item #000013 South West Flavor, Use By 7/13/16, 7/21/16, 7/28/16, 8/4/16, 8/11/16 ; Food Service: Item #001113 South West Flavor; Use By 7/13/16, 8/11/16 Class II Gluten testing was performed on products labeled gluten free. The results received back were >20ppm. Sunshine Burger & Specialty Food Company, LLC
Food Organic Sunshine Burgers Gluten Free Soy Free Vegan Loco Chipotle 2 Organic Veggie Burgers Keep Frozen Net WT: 8 OZ. Use By: 8/12/16 Retail: Item # 003163 Loco Chipotle Flavor; Use By 8/12/16 Class II Gluten testing was performed on products labeled gluten free. The results received back were >20ppm. Sunshine Burger & Specialty Food Company, LLC
Food Walnuts Halves & Pieces Net Weight 16-oz 454.0 Grams UPC: 0078264065165 Hines Nut Company Dallas, Texas 75201; Walnuts Halves & Pieces Net Weight 12-oz 340.5 Grams UPC: 0078264065127 Hines Nut Company Dallas, Texas 75201; Harris Teeter Farmers Market Walnut Meats Net Weight 10 OZ. (284g) UPC: 072036881144 Lot Code: 6908; Hines Nut Company Best By Dates: September 21, 2015 to October 1, 2015; Harris-Teeter Best By Dates: September 28, 2015. Class I Product may be contaminated with Salmonella. Hines Nut Co
Food Organic Sacha Inchi Powder, 8oz. white poly bags, UPC 803813-28444 1. Organic Sacha Inchi Powder, bulk. Lot No. 141027 (retail), 141111 (bulk). Class II Sunfood is recalling Sacha Inchi Powder because it has the potential to be contaminated with Staphylococcus enterotoxin. Sunfood Corportation
Food 1lb mungbean sprouts 15 box (20 bags a box) a week. 10lb mungbean sprouts 30 bag a week. These products are labeled as produced by Henrys Farm Inc The packages were not coded Class I Listeria contamination was discovered at Henry's Farm, Inc., a grower and manufacturer of soybean sprouts, after sampling by the US Food and Drug Administration. Sample 875780 . Henrys Farm Inc. of Woodford, VA is recalling all packages of Soybean Sprouts because they may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections to individuals with weakened immune systems. Although healthy individuals may suffer only short term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Henrys Farm Inc.
Food 1lb soybean sprouts 30 box (20 bags a box) a week.10lb soybean sprouts 60 bags a week. These products are labeled as produced by Henrys Farm Inc The packages were not coded Class I Listeria contamination was discovered at Henry's Farm, Inc., a grower and manufacturer of soybean sprouts, after sampling by the US Food and Drug Administration. Sample 875780 . Henrys Farm Inc. of Woodford, VA is recalling all packages of Soybean Sprouts because they may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections to individuals with weakened immune systems. Although healthy individuals may suffer only short term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Henrys Farm Inc.
Food farm to table meals : Lentil and Barley. This is a dried soup/chili mix which contains lentils and barley in a large zip lock plastic bag along with a small zip lock bag of a chili spice packet. The spice packet contains the recalled cumin. Each plastic zip lock bag has a label affixed to it. The outer label is yellow/orange and black and has a tomato drawing on it. Net. WT. 16 oz. The date of repacking is stamped on the package. Date is stamped on the bottom of the information panel. It contains the three letter abbreviation for the month in capital letters followed by the two digit day and 4 digit year. Example FEB 02 2015. Class II Food for Lane County received and repackaged a product containing cumin which is being recalled due to the potential of being contaminated with peanut protein. Food for Lane County
Food Whole Foods Market "Chocolate Cake for Two" UPC code: 246357004999 Net Wt. 11 oz (0.69lb) in a clear plastic "clam shell" container. PLU#46357 Best by dates: 02/03/2015 to 02/18/2015 Class I Product contains undeclared eggs. Whole Food Market
Food Price Rite Ground Cumin, Net Wt. 3 oz, UPC 041190761135 N/A Class I Colonna Brothers is recalling ground cumin received from its supplier that may be contaminated with peanut proteins. Colonna Brothers Inc.
Food Cremosa Ground Cumin, Net Wt. 1 LB (16 oz.), Dist. By Cremosa Food Company, LLC, 5 Park Drive, Melville, NY 11747 N/A Class I Colonna Brothers is recalling ground cumin received from its supplier that may be contaminated with peanut proteins. Colonna Brothers Inc.
Food E & S Ground Cumin, Net Wt. 1 LB (16 oz.), E & S Foods, Inc., Whippany, NJ 07981, UPC 000000130059 N/A Class I Colonna Brothers is recalling ground cumin received from its supplier that may be contaminated with peanut proteins. Colonna Brothers Inc.
Food Breyers® No Sugar Added Salted Caramel Swirl 1.5-quart (1.41L) packaged in paperboard tubs Unilever, Englewood Cliffs, NJ 07632 USA Unit UPC: 7756738393. Product sold as 1.5-quart (1.41L) paperboard tubs, delivered to retailers in shrink wrap. Case UPC: 10077567383935 NOV2915GB Class I Unilever United States, Inc. is voluntarily recalling a limited number of tubs of Breyers® No Sugar Added Salted Caramel Swirl because they may inadvertently contain almonds, which are not listed as an ingredient on the label. Unilever United States, Inc.
Food Natural Grocers brand Organic Garlic Powder. Natural Grocers brand Organic Garlic Powder. Packaged in Zip-Lock-type plastic bags, labeled by random weight, average 0.28 lb. per package, distributed in 25 lb. cases. Packed by Vitamin Cottage Natural Grocers, Inc., Lakewood, CO. Julian Packed on Date: 61-15, 40-15, 20-15, 351-14, 006-15, 316-14, 329-14, 288-14, 301-14, 275-14, 267-14, 252-14, 237-14 Class I Vitamin Cottage Natural Food Markets, Inc. is recalling two lots of Natural Grocers brand Organic Garlic Powder because it has the potential to be contaminated with Salmonella. Vitamin Cottage Natural Food Markets, Inc.
Food Assorted Milk Chocolate Royal Icing Pops sold as Assorted Character Icing Pops, Christmas Icing Pops, and Triple Heart Icing Pops, 24 pops per box. The Milk Chocolate Icing Pops are made to order and sold in unmarked bulk boxes. Each Milk Chocolate Icing Pop is individually wrapped for retail sale in 2 oz. clear cellophane with a curl ribbon closure. Uncoded; distributed September 2014 through February 1, 2015 Class I The products contain undeclared egg and FD&C colors Yellow 5 or 6, Red 3 or 40, and/or Blue 1 from the royal icing component used on the finished pops. Chocolate By Design, Inc.
Drugs Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials, For Intravenous or Intramuscular Use, Preservative Free, Rx Only, Manufactured by: West-Ward Pharmaceuticals, Eatontown, NJ 07724, NDC 0641-6028-25. Lot #: 113312, Exp 11/2015; 014315 Exp 01/2016 Class III Failed Impurities/Degradation Specifications; 12 month stability testing. West-Ward Pharmaceutical Corporation
Food UNCLE BEN'S(R) Ready Rice(R) ROASTED CHICKEN FLAVORED with Carrots and Herbs, Net Wt 8.8 oz (250 g), Codes: 506AKGRV17, Best by 2/1/2016; 506ALGRV17, Best by 2/1/2016; 506AMGRV17, Best by 2/1/2016; 506BKGRV17, Best by 2/1/2016 Class II UNCLE BENS(R) Ready to Heat Pouches have the potential for containing metal fragments. Mars Food US
Food UNCLE BEN'S(R) Ready Rice(R) BUTTER & GARLIC FLAVORED, Net Wt 8.8 oz (250 g), Codes: 504FMGRV16, Best by 1/1/2016; 505GKGRV17, best by 1/1/2016; 505GMGRV17, Best by 2/1/2016 Class II UNCLE BENS(R) Ready to Heat Pouches have the potential for containing metal fragments. Mars Food US
Food UNCLE BEN'S(R) Ready Rice(R) NEW ORLEANS STYLE RED BEANS & RICE, with a blend of smokey, savory seasonings, Net Wt 8.5 oz (240 g), Codes: 506AKGRV16, Best by 2/1/2016; 506ALGRV16, Best by 2016; 506AMGRV16, Best by 2/1/2016 Class II UNCLE BENS(R) Ready to Heat Pouches have the potential for containing metal fragments. Mars Food US
Food UNCLE BEN'S(R) Ready Rice(R) BEEF FLAVOR with carrots and herbs, Net Wt 8.5 oz (240 g), Codes: 505AKGRV17, Best by 2/1/2016; 505FMGRV17, Best by 2/1/2016 Class II UNCLE BENS(R) Ready to Heat Pouches have the potential for containing metal fragments. Mars Food US
Food UNCLE BEN'S(R) Ready Rice(R) ORIGINAL, ENRICHED LONG GRAIN WHITE RICE, Net Wt 8.8 oz (250 g), Code: 506BLGRV16, Best by 02/01/2016 Class II UNCLE BENS(R) Ready to Heat Pouches have the potential for containing metal fragments. Mars Food US
Devices Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0. The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. Aaren Scientifics EC-3 IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by phacoemulsification. Serial No. 1181331102, 1181321102, 1393231208, 1117161211, 1180941102, 1031031102, 1190261307, 1190231307, 1190091307, 1190101307, 1190431307, 1190441307, 1276591307, 1305951307, 119071307, 1176951102, 1192921102, 1277111307, 1189541307, 1189551307, 1187761307, 1189531307, 1309911307, 1277101307, 1181331102, 1181321102, 1393231208, 1117161211, 1180941102, 1031031102, 1190261307, 1190231307, 1190091307, 1190101307, 1190431307, 1190441307, 1276591307, 1305951307, 1190071307, 1176951102, 1192921102, 1277111307, 1189541307, 1189551307, 1187761307, 1189531307, 1309911307, 1277101307,  ...
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Class II Aaren Scientific is recalling intraocular lenses because the instructions for use (IFU) are not fully compliant with US requirements. Aaren Scientific, Incorporated
Food Organic Chocolate Hazelnut Butter with Fair Trade 65% Dark Chocolate, Item no. N270. Product is sold under Hummingbird brand, packaged in 1 lb. (454 gram) glass jar with white metal lid. The UPC is 6-96859-11035-1. Lot 15023 (represents Julianne date of manufacture) Class I Hummingbird Brand Organic Chocolate Hazelnut Butter is recalled due to undeclared milk. Hummingbird Wholesale
Drugs Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00) packaged in cartons of five (NDC 67457-409-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103 Lot 7602281, Exp 4/16; Lot 7602283, Exp 4/16 Class II Lack of Assurance of Sterility; due to leaking vials Mylan Institutional LLC
Drugs Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packaged in cartons of ten (NDC 67457-410-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103 Lot 7602368, Exp 7/16; Lot 7602369, Exp 7/16 Class II Lack of Assurance of Sterility; due to leaking vials Mylan Institutional LLC
Food HAZELNUTS (FILBERTS), varying weights up to 16 oz., Item Code 228119 XXXXXX --- PACKAGED BY FAIRWAY MARKET, 2284 12TH AVENUE, NEW YORK, NY 10027 --- The product is packaged in clear, plastic cello bags of varying weights, each weighing less than one pound. Item Code 228119 XXXXXX (last six digits vary due to weight and price). All "SELL BY" Date codes of May 15, 2015 and earlier Class I The product was found to be contaminated with Salmonella based on sampling and analysis. Fairway Operating Corp.
Food Cocola Macaroons; Each box contains 5 flavors (3 ct each): Mango Passion, Raspberry, Pistachio, Coffee, and Chocolate. Net wt. 7 oz. ; UPC 091037037985. Ingredient: Fresh Egg White, Mango Puree, Passion Fruit Puree, Granulated sugar, powdered sugar, Almond Flour,Butter N&A color, coffee extract, sour cream, cream, cacao nibs, dark chocolate. Contains Eggs, Dairy, Nuts Cocola, 2810 Bay Rd., Redwood City, CA 94063 Best by 02/19/2015 Best by 03/05/2015 FMS01915 FMS03315 Class II Complaint received from NYSDAM regarding undeclared colors in Cocolo cookies. Cocola INC
Food 8 in. sundried tomato flavored tortilla wraps, packaged in re-sealable polypropylene bags, 10 wraps per bag. Sold under the El Popocatepetl brand name. UPC Code: 0 20784 99505 7 Lot Codes: 15006, best by: 2/20/2015** 15024, best by: 3/27/2015** 15029, best by: 4/1/2015 Class I El Popocatepetl Ind., Inc. of Chicago, Illinois is voluntarily recalling El Popocatepetl's 8 in. Chipotle, Spinach Pesto, and Sun Dried Tomato Wraps because they may contain undeclared milk and Yellow No. 5. El Popocatepetl Ind., Inc.
Food 8 in. spinach pesto flavored tortilla wraps, packaged in re-sealable polypropylene bags, 10 wraps per bag. Sold under the El Popocatepetl brand name. UPC Code: 0 20784 58314 8 Lot Codes: 15006, best by 2/20/2015** 15015, best by 3/1/2015** 15024, best by 3/27/2015** 15029, best by 4/1/2015** 15038, best by 3/24/2015 Class I El Popocatepetl Ind., Inc. of Chicago, Illinois is voluntarily recalling El Popocatepetl's 8 in. Chipotle, Spinach Pesto, and Sun Dried Tomato Wraps because they may contain undeclared milk and Yellow No. 5. El Popocatepetl Ind., Inc.
Food 8 in. chipotle flavored tortilla wraps, packaged in re-sealable polypropylene bags, 10 wraps per bag. Sold under the El Popocatepetl brand name. UPC Code: 0 20784 78248 0 Lot Codes: 15006, best by: 2/20/2015** 10524, best by: 3/7/2015** 15029, best by: 4/1/2015 Class I El Popocatepetl Ind., Inc. of Chicago, Illinois is voluntarily recalling El Popocatepetl's 8 in. Chipotle, Spinach Pesto, and Sun Dried Tomato Wraps because they may contain undeclared milk. The milk ingredient was found in the "butter flavoring" which was used in all three flavored wraps. El Popocatepetl Ind., Inc.
Devices Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. Endo TCS driver is one of the instruments within the surgical tray for use with the Interbody Fusion Device(IBD). G150101 Class II Titan Spine, LLC became aware of the TCS Straight Hexlobular #6 Drivers (5210-1004) tip shearing off during use in procedures that involved patients with dense bones. As a result of this malfunction, Titan Spine, LLC is removing all of the TCS Straight Hex lobular #6 Drivers (5210-1004) Lot# G150101 from the field. TITAN SPINE, LLC
Devices Flower Orthopedics Small and Medium Implants Set; Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm , Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm x L:20.0mm; Variable Angle Locking Peg, D:1.8mm x L:22.0mm ; Variable Angle Locking Peg, D:1.8mm x L:24.0mm; Variable Angle Locking Peg, D:1.8mm x L:26.0mm; the locking pegs are intended to be used in conjunction with the Flower Orthopedics Distal Radius Plate for osteosynthesis of the radius bone. All lots of Catalog Numbers: FLP 114, FLP 116, FLP 118, FLP 120, FLP 122, FLP 124, FLP 126 Class II Locking pegs were not locking during distal radius procedures. There has been one (1) report of revision surgery scheduled to remove a loosened peg. Flower Orthopedics Corporation
Devices BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. An accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids. Lot #'s 4128925 and 4128926 Class II Becton Dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tearing of the silicone septum. Becton Dickinson & Company
Devices Coblator II System, 120V. Product Usage: The Coblator II (Model RF8000E) is a bipolar, radiofrequency electrosurgical system designed for use in otorhinolaryngology (ENT) surgery. The system consists of the following components: an electrosurgical radiofrequency controller, a reusable, non-sterile Power Cord; a reusable, non-sterile Foot Control; a reusable, non-sterile Flow control Valve Unit; a reusable, non-sterile flow control cable; a single use, disposable, sterile Wand. The Coblator II is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery. Serial Numbers: CA0N0000FT, CA0N0000H0, CA0N0000H7, CA0N0000J6, CA0N0000KJ, CA0N0000KK, CA0N0000KL, CA0N0000FW, CA0N0000G5, CA0N0000G6, CA0N0000H1, CA0N0000FR, CA0N0000FZ, CA0N0000KF, CA0N0000GH Class II The recalling firm was notified by the contract manufacturer that they had reversed the L2, L3, L4, or L5 components on the P/N09010 RoHS boards of the Coblator II Controller (Model RF8000E). ArthroCare Medical Corporation
Food Vital Wheat Gluten Agridient, 50 lb. paper sack Production date: December 2014 Expiry date: December 2017 Batch No. NO81114-P3 Lot 53656 & Batch No. N081114-P3, Lot 53657 net wt 50# Class I Agridient Inc. received information that gluten they had repackaged and distributed contained undeclared allergen peanut. Agridient Inc. distributed gluten with undeclared allergen peanut to two customers and issued notice of recall to one customer on 02/05/2015, and the second customer on 02/21/2015 via emailed letter. Agridient, Inc.
Devices Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.5 x 13.63 x 3.75") within a secondary corrugated shipper (16 x 11.02 x 5.12" inner dimensions). The device is indicated for assisted expression of milk using manual suction. SKU 17161; Lot 5A22 Class II Devices were not sterilized Ameda, Inc.
Devices Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouches with Tyvek header (10.75 x 16.375 x 3") within a secondary corrugated shipper (20.75 x 15.50 x 8.5" inner dimensions). The device is intended to be connected to a powered breast pump or adapted for use with a manual breast pump to express and collect the mother's milk of a nursing woman for the purpose of feeding the collected milk to a baby. SKU 17115; Lot 5B01 Class II Devices were not sterilized Ameda, Inc.
Devices NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage: Intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution-Rotating Hinge Knee (RHK) System, the Trabecular Metal Augments are for cemented use only. When used with the NexGen Complete Knee Solution-Legacy Constrained Condylar Knee System, the Trabecular Metal Augments are for cementless or cemented use. 20 MM - Part No. 00-5490-034-24, Lot #613574282T 5 MM - Part No. 00549003410, Lot #61357484T Class II One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed. Zimmer Trabecular Metal Technology, Inc.
Devices Alaris PC units, Model No. 8015. Infusion pump. Serial No. 13874997 13875013 13875014 13875053 13875060 13875186 13875188 13875192 13875198 13875200 13875202 13875203 13875251 13875252 13875301 13875407 13875437 13875556 13875674 13875985 13876089 13876108 13876859 13877010 13877031 13877035 13877044 13877050 13877077 13877093 13877119 13877201 13877238 13877274 13877279 13877364 13877378 13877381 13877383 13877409 13877425 13877443 13877514 13877515 13877533 13877763 13877783 13877807  ...
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Class II CareFusion is recalling the Alaris PC unit because of an error code. The error code may occur upon power on during the "Power-On Self Test" due to a keypad issue. CareFusion 303, Inc.
Biologics Red Blood Cells W050911072857 Class III Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. HCSC-Blood Center
Biologics Red Blood Cells Leukocytes Reduced W036314010252 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. BloodCenter of Wisconsin, Inc
Biologics Recovered Plasma W036314010252 Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. BloodCenter of Wisconsin, Inc
Biologics Red Blood Cells Leukocytes Reduced W333615011639 Class II Blood product, collected from a donor who emigrated from an area considered endemic for malaria, was distributed. Mississippi Valley Reg Bld Ctr
Food Stonewall Kitchen Buffalo Wing Sauce Net Wt. 17.5 oz. glass jar UPC 711381-31395 4 Item # 251805, Enjoy By Date: 06Feb2017 Class II Undeclared soy lecithin Stonewall Kitchen, LLC
Devices ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures.. ExacTrac versions 6.x including versions 6.0.0, 6.0.1, 6.0.2, 6.0.3, 6.0.4, 6.0.5; and v. 6.1.0. Model/Catalog Numbers: 49971, CBCT IMPORT & ALIGNMENT SOFTWARE; 20836, EXACTRAC 6.0 VARIAN CBCT LICENSE; The software may be contained in configured items: 48320, ET UPGRADE SOFTWARE 6.0 TO 6.1; 48320-99, ET UPGRADE SOFTWARE 6.0 TO 6.1  ...
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Class II The ExacTrac 6.x Patient Positioning System may incorrectly position the patient when using the ExacTrac Cone Beam CT (CBCT) with a TrueBeam-specific optional subvolume-CBCT. Brainlab AG
Devices RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. RayStation is a software system designed for treatment planning and analysis of radiation therapy. Build numbers 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.4, 4.5.0.19, 4.5.1.14 and 4.7.0.15 Class II RaySearch Laboratories AB became aware of an issue found with photon dose calculation for DMLC (Dynamic MLC) plans for machines where the MLC is positioned above the jaws, e.g. some Elekta linacs. The magnitude of the error depends on the beam model output factor corrections and on the individual DMLC plan characteristics. RAYSEARCH LABORATORIES AB
Devices GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Contour, Brivo MR355, Optima MR360, GE 1.5T SIGNA HDE MR SYSTEM, Signa Openspeed 0.7T MR SYSTEM, Vectra, SIGNA 0.35T OVATION WITH EXCITE, SIGNA 0.2T PROFILE With EXCITE MRI Systems Mfg Lot or Serial # System ID 00000301098MR0 AL4023MR01 AL4004MR01 AL4009MR01 00000346726YM3 DZ1004MR01 000000HDMR5247 DZ1009MR02 00000267807MR6 DZ1057MR01 00001251FMM01J DZ1006MR01 00000305201MR6 DZ1101MR01 000000HDMR6342 DZ1250MR01 00000002790M24 DZ1396MR01 00000000175M20 DZ1102MR01 00000311125HM9 DZ1072MR01 00000004368M27 DZ1547MR01 00000003534M25 DZ1339MR02 00000005640M28 DZ1339MR01 00001010BD6611 DZ1090MR01 00000015868GQ3 DZ1259MR01 00001011BD667C DZ1005MR01 00000272532MR3 DZ1193MR01 00000005809M29 DZ1598MR01 00000311119HM2 DZ1061MR01 000000HDMR5358 DZ1260MR01 00000290691MR5  ...
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Class II GE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites. GE Healthcare
Devices The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the users walking style and environment. The RHEO KNEE recognizes and responds immediately to changes in speed, load and terrain, restoring the users ability to walk naturally, comfortably and confidently at any speed. Rheo 2 Item Number: RKN120007 Serial #s affected: 323056 321498 Class II The firm is recalling Rheo Knee bionic prosthetic due to it being discovered during an internal audit of the service line that devices were released for distribution without fully going through the assembly process. Ossur H / F
Devices da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Material number: 380662-20 and 380662-21. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endscopic retractors, electrocautery and accessories for edoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic labaroscopic surgical procedures, general thorascopic surgical procedures and thorascopically-assisted cardiotomy procedures. Material number: 3680662-20: Serial numbers: 1311140273, 1311140370, 1311140385, 1311140148, 1311140099, 1311140152, 1311140081, 1311140473, 1311140561, 1311140409. Material number: 380662-21: Serial numbers: 1311140225, 1311140437, 1311140476, 1311140336, 1311140472, 1311140438, 1311140353, 1311140195, 1311140545, 1311140098 1311140189, 1311140465, 1311140394, 1311140366, 1311140008, 1311140115 1311140014, 1311140371, 1311140238, 1311140306, 1311140332, 1311140404 1311140054, 1311140188, 1311140324, 1311140453, 1311140408, 1311140237 1311140220, 1311140372, 1311140325, 1311140088, 1311140535, 1311140355. Class II Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch between the positions reported by the redundant position sensors on one of the patient cart arm joints. Intuitive Surgical, Inc.
Devices da Vinci Xi Surgical System, IS4000; ASSY,DISTAL SUJ,OUTER,IS4000, Material number: 380663-20 and 380663-21. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endscopic retractors, electrocautery and accessories for edoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic labaroscopic surgical procedures, general thorascopic surgical procedures and thorascopically-assisted cardiotomy procedures. Material number: 380663-20; Serial numbers: 1311140532, 1311140035, 1311140475, 1311140424, 1311140196, 1311140146, 1311140252, 1311140010, 1311140289, 1311140578, 1311140435, 1311140349, 1311140411, 1311140389, 1311140156, 1311140198, 1311140452, 1311140186, 1311140554 1311140335, 1311140249. Material number 380663-21: Serial numbers: 1311140047, 1311140541, 1311140181, 1311140352 1311140023, 1311140165, 1311140159, 1311140126, 1311140571, 1311140397, 1311140130, 1311140318, 1311140180, 1311140151 1311140375, 1311140428, 1311140528, 1311140263, 1311140169 1311140443, 1311140537, 1311140544, 1311140419, 1311140006 1311140583, 1311140173, 1311140154. Class II Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch between the positions reported by the redundant position sensors on one of the patient cart arm joints. Intuitive Surgical, Inc.
Devices da Vinci Xi Surgical System, IS4000; ASSY,USM,IS4000, Material number: 380647-20 and 380647-22 The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endscopic retractors, electrocautery and accessories for edoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic labaroscopic surgical procedures, general thorascopic surgical procedures and thorascopically-assisted cardiotomy procedures. Material number: 380647-20; Serial numbers: 1311140430, 1311140586, 1311140058, 1311140392. 1311140277, 1311140307, 1311140094, 1311140100, 1311140569, 1311140102, 1311140421, 1311140092, 1311140009, 1311140070, 1311140267, 1311140333, 1311140492, 1311140391, 1311140057, 1311140294, 1311140508, 1311140565, 1311140105, 1311140122, 1311140469, 1311140521, 1311140378, 1311140456, 1311140230 1311140573, 1311140065, 1311140164, 1311140194, 1311140511, 1311140291, 1311140304, 1311140212, 1311140222, 1311140001, 1311140137, 1311140344, 1311140381, 1311140341, 1311140538, 1311140168, 1311140523, 1311140274, 1311140033, 1311140091 1311140248, 1311140141, 1311140436, 1311140418, 1311140548 1311140320, 1311140170,  ...
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Class II Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch between the positions reported by the redundant position sensors on one of the patient cart arm joints. Intuitive Surgical, Inc.
Devices MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis. The MAGNETOM systems may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-safe biopsy needles. model numbers: 10432914, 10432915, 10684331, 10684332, 10684333, 10684334 with serial numbers: 45398 45788 59092 60099 41953 45805 52255 45812 52250 52171 52264 41980 41448 60092 41727 60038 60062 59071 59065 60061 60082 62032 41548 52168 59032 62014 60086 57118 52108 41628 60070 45249 62027 41699 41701 59090 60060 60052 41903 52082 41473 45537 41749 41457 42060 41383 41769 45778 62018 45628 52200 42033 52135 52195 41317 41529 45371 57060 41862 59101 52150 52240 52128 41608 41624 42012 45160 45387 45603 45526 41476 45155 52251 41746 62020 41503 59120 62024 59096 62025 41897 59109 45681 41362 60053 60055 59087 60085 41819 59116 62031 52172 52057 52153 45623 59112 41844 41874 59104 45850 41621 52192 60054 41595 45667 41353 60063 57254 41556 60079 45408 41654 52021 52072 57146 45239 59035 59076 41629 41802 41952 45230 45251 41979 45237 45205 45694 41671 45507 41389 41295 60091 Class II The gradient output supervision was permanently turned off on the MAGNETOM system, meaning that gradient outputs could exceed IEC60601-2-33 limits and peripheral nerve stimulation could occur. Siemens Medical Solutions USA, Inc
Drugs AIR COMPRESSED, Medical Air, USP, Rx Only. Matheson Tri-Gas, Inc., 150 Allen Road, Basking Ridge, NJ 07920. Available in A) E or 22 cu ft cylinder, NDC: 55037-302-09; B) 40 cu ft cylinder, NDC: 55037-302-10; C) 200 cu ft cylinder, NDC: 55037-302-15; D) 220 cu ft cylinder, NDC: 55037-302-16; E) 300 cu ft cylinder, NDC: 55037-302-18, 55037-302-19, 55037-302-20. A) Lot #: BAHC564281A, BAHC564281B, BAHC546288A, BAHC564288B, BAHC546288C, BAHC546288D, BAHC546288E, BAHC564307A, BAHC564314A, BAHC564329A. BAHC564329B, BAHC564329C, BAHC564329D, BAHC564329E, BAHC564344A, BAHC565005A, BAHC565006A, BAHC565013A, BAHC565015A, BAHC565015B, BAHC565015C, BAHC565015D, BAHC565029A, BAHC565035A. BAHC565035B, BAHC565035D; B) Lot #: BAHC564282A, BAHC564296A, BAHC564303A, BAHC564344A, BAJC565016A, BAHC565034A, BAHC565043A, BAHC565054A; C) Lot #: BAHC564269A, BAHC564275A, BAHC564282A, BAHC564288A, BAHC564296A, BAHC564303A, BAHC564308A,  ...
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Class III Failed Impurities/Degradation Specification; out of specification results for carbon dioxide Matheson, Inc.
Devices Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions. 107046, 106992, 106993, 106990. Class I The OAD saline sheath outer layer may flake off from the catheter due to friction between the outer material layer and corresponding materials it may come in contact with during clinical use. If the material is large enough, it has the potential to cause a flow limiting embolism. Cardiovascular Systems, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W280814003893 Class III Blood product, collected from an ineligible donor, was distributed. Roswell Park Cancer Institute Corporation. Div. of Pathology
Biologics Platelets Pheresis Leukocytes Reduced W2084148077991; W208414807799; Class II Plateletpheresis products, lacking assurance of proper leukoreduction, were distributed. American National Red Cross (The)
Devices DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant. Batch numbers: 1404032, 1412011 Class II Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder. In2Bones, SAS
Devices DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant. Batch numbers: 1412021 Class II Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder. In2Bones, SAS
Drugs 0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0049-03 Lot #: C929844, Exp 5/31/2015; C926873, Exp 4/30/2015; C928630, Exp 4/30/2015. Class II Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility. Baxter Healthcare Corp.
Drugs 5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0017-04 Lot #: C926899, Exp 7/31/2015 Class II Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility. Baxter Healthcare Corp.
Biologics Platelets Pheresis Leukocytes Reduced W038615850449 (2 units) Class II Blood products, with a platelet yield that exceeded the maximum specification, were distributed. Suncoast Communities Blood Bank, Inc.
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