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U.S. Department of Health and Human Services

Enforcement Report - Week of March 27, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced V10279A; V10279B Class II Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed. Blood Center of Central Iowa (The)
Biologics Red Blood Cells Leukocytes Reduced LX63739 Class III Blood product, which was labeled with an incorrect expiration date, was distributed. Blood Center of Central Iowa (The)
Biologics Platelets Pheresis Leukocytes Reduced 20LR16622 Class II Blood products, collected from a donor whose arm scrub procedure was performed incorrectly, were distributed. American National Red Cross (The)
Biologics Fresh Frozen Plasma (Apheresis) 20LR16622 Class II Blood products, collected from a donor whose arm scrub procedure was performed incorrectly, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 020LN57617 , 020LN57588 , 020LN57632 , 020LN57626 , 020LN57591 , 020LN57638 , 020LN57584 , 020LY55252 , 020LC71725 , 020LC71693 , 020LY55273 , 020LY55260 , 020LY55275 , 020LY55254 , 020LN57623 , 020LY55256 , 020LZ26853 , 020LZ26857 , 020LZ26850 , 020LC71703 , 020LZ26855 , 020LY55263 , 020LY55258 , 020LY55257 , 020LY55255 ,  ...
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Class II Blood products, which were collected from donors in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Fresh Frozen Plasma 020LY55252. Class II Blood products, which were collected from donors in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Fresh Frozen Plasma 020LN57613, 020LN57641, 020LN57605. Class II Blood products, which were collected from donors in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 20LN57900 Class II Blood product, collected from a donor who traveled to a malarial endemic area, was distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 020LN52994 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 020LZ30286; 020LH19466. Class III Blood products, which may have been exposed to unacceptable temperatures during storage, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 2833695 Class II Blood product, collected from a donor who was taking the drug Prednisone, were distributed. Hoxworth Blood Center University of Cincinnati Medical Center
Biologics Red Blood Cells Leukocytes Reduced 021KY12152 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross
Biologics Plasma Frozen 021KY12152 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross
Biologics Platelets Pheresis Leukocytes Reduced W037908113997 Class II Blood product, which was labeled as leukoreduced, but was not tested to verify the White Blood Cell count, was distributed. LifeServe Blood Center
Biologics Red Blood Cells Leukocytes Reduced W038308070193; W038308070195; W038308072208; W038308072210; W038308072212; W038308072213; W038308072214; W038308072216; W038308072217; W038308072219; W038308072220; W038308072221; W038308072222; W038308072226 Class III Blood products, held in transit storage container for 24 hours and possibly exposed to unacceptable temperatures, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Platelets Pheresis Leukocytes Reduced W038308001621(part 1); W038308001622 (part 1); W038308001621(part 2); W038308001622 (part 2) Class III Blood products, held in transit storage container for 24 hours and possibly exposed to unacceptable temperatures, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells Leukocytes Reduced W038308023614 Class III Blood product, manufactured without the entire quantity of additive solution, was distributed. Mississippi Valley Reg Bld Ctr
Biologics Source Plasma 037308105, 037308106, 037308107, 037308107A, 037308108, 037308109, 037308109A, 037308114A Class III Blood products, which may have been exposed to unacceptable temperatures during storage, were distributed. Talecris Plasma Resources, Inc.
Biologics Red Blood Cells W127808301997. Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Tacoma-Pierce County Blood Bank
Biologics Source Plasma 375045485; 375048882; 375049084; 375049221; 375055501; 375055797; 375056342; 375057428; 375057950; 375049063; 375053713; 375057572; 375049008; 375049023; 375050131; 375050997; 375051299; 375051912; 375052053; 375052633; 375052819; 375049119; 375049164; 375050974; 375051238; 375051638; 375051869; 375053244; 375049122; 375049150; 375043877; 375044054; 375044502; 375044681; 375050865; 375051086; 375051569; 375052169; 375052257; 375052818; 375052961; 375054020; 375054135; 375054609; 375054769; 375055355; 375055404; 375055951; 375056080; 375056776;  ...
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Class II Blood products, collected from donors who did not have a complete physical examination, were distributed. Talecris Plasma Resources, Inc.
Devices ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine, Inc. The ILLICO® MIS Posterior Spinal Fixation System is intended to facilitate the surgical correction of non-cervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. Lot # 635436; Part #73601-110 Class II The rods were incorrectly laser etched as ILLICO® Straight CP Tl Rods, 110mm, when they were in fact manufactured to 100mm in length. Alphatec Spine, Inc.
Biologics Fresh Frozen Plasma 06FE30808; 06FE30810; 06FE30814; 06FE30820; 06FY91231; 06FY91236; 06FY91247; 06FY91313; 06FY91320; 06FY91342; 06FY91348; 06FY91351; 06FY91355; 06FY91356; 06FY91374; 06FY91391; 06FY91394; 06FY91405 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross (The)
Biologics Plasma Frozen within 24 Hours After Phlebotomy (FP24) 006fy93230; 006gv77545; 006ge03248; 006fc59791; 006fc59790; 003gx8824; 006gx88853; 006fe31590; 006fe31594; 006gx88583; 006fr07331; 006fr07309; 006fy91348; 006fy91374; 006gg04309; 006lt84124; 006gt77187; 006fc60206; 006gv77634; 006fy91381; 006fy91405; 006lh17613; 006lh17618; 006lt84157; 006fc61113; 006gw55907; 006fe32874; 006gp97396; 006fy92831; 006fc50784; 006fe33660; 006lh16752; 006gt76426; 006fy92836; 006fe31486; 006fy91545; 006fy91462; 006fy91430; 006fy91342; 006lt84151; 006gt77353; 006gt77080; 006gt77097; 006gt77085; 006fe32661; 006gv77524; 006gv77539; 006gv77529; 006lh16795; 006lh16791;  ...
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Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 006LH17884; 006GT77083; 006FE32665; 006GV77287; 006FY92834; 006GT76448; 006GX88821; 006FC59395; 006FC59400; 006FC59379; 006FC59396; 006FY93532; 006GE34211; 006LT85275; 006LP45417; 006FC61113; 006LP45394; 006LY83109; 006FE33850; 006LV50513; 006LV50490; 006LV50608; 006LQ04201; 006GX90106; 006GX90110; 006LT85283; 006FY93527; 006FY93530; 006FY93510; 006LY83107; 006LH17616; 006LV50512; 006lv50488; 006lv50506; 006FY93684; 006FY93514; 006LP45234; 006GE34215; 006GS40462; 006LY83121; 006LY83089; 006LY83117; 006FC60182; 006LY83118; 006GE34230; 006LQ04205; 006GQ64197; 006GT77323; 006LH17618; 006LH17613;  ...
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Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross (The)
Biologics Cryoprecipitated AHF, Pooled 006L18545; 006L15866; 006L15054; 006L16546; 006L16578; 006L15055; 006L15867; 006L16869; 006L16558; 006L16863; 006L15843; 006L15842; 006L15092; 006L15039; 006L15071; 006L16707; 006L16551; 006L16589 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross (The)
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 006LP45217; 006LQ03498; 006LP45821; 006LS18807; 006GS40378; 006GQ64179; 006LP46627; 006LP46623; 006LP45625; 006GW55908; 006GS40379; 006GX900069; 006GW55918; 006GW55917; 006LQ03495; 006LQ03496; 006LP45623; 006LP45627; 006LP45625; 006GW55808; 006LT85266- PART 1; 006LT85266- PART 2; 006LP45217; 006GE34207- PART 1; 006GS40378; Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross (The)
Biologics Cryoprecipitated AHF 006GQ64197 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Irradiated 006LV5047; 006LV5050; 006FE3299; 006FE3297; 006FE32995; Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross (The)
Food The pizza dough shells come in 5 lb. brown cardboard boxes, containing 25 shells per box. None. Class II There is no labeling on the product, and the product contains the allergen, wheat. Ron's Pizza Warehouse
Food Dymatize Nutrition XPAND Post Xtreme Mass Recovery System Lemonade 3.5 lb Manufactured & Distributed by Dymatize Enterprises, LLC, 13737 N. Stemmons FWY. Dallas, TX 75234 UPC 705016895649 Lots 1244001, 1292001, 1021101, 1075102, and 1276102. Class I The product label declares whey but does not declare milk. Dymatize Enterprises, LLC
Food Dymatize Nutrition XPAND Post Xtreme Mass Recovery System Fruit Punch 3.5 lb Manufactured & Distributed by Dymatize Enterprises, LLC, 13737 N. Stemmons FWY. Dallas, TX 75234 UPC 705016895625. Lots 1244003, 1292006, 1340011, 1021107, 1075104, 1151111, and 1307105. Class I The product label declares whey but does not declare milk. Dymatize Enterprises, LLC
Food Dymatize Nutrition XPAND Post Xtreme Mass Recovery System Blue Raspberry 3.5 lb Manufactured & Distributed by Dymatize Enterprises, LLC, 13737 N. Stemmons FWY. Dallas, TX 75234 UPC 705016895601. Lots 1292004, 1244004, 1025102, 1075115, and 1153101. Class I The product label declares whey but does not declare milk. Dymatize Enterprises, LLC
Food Grilled Chicken Marinade, IFF Code 3559317, Net Weight 50 Lb, Batch 0004700696, 004705802, and 004722458, Production Date 04/20/2012 and 05/01/2012, For Manufacturing Use Only. IFF Code 3559317, Batch 0004700696, and Production Date 04/20/2012. Class I Product has the potential to be contaminated with Salmonella. International Flavors & Fragrances, Inc
Food Natural Chicken Flavor Seasoning, IFF Code: 3714201, Net Weight 50 lbs, Batch 0004706362, Production Date 04/25/2012, For Manufacturing Use Only. IFF Code: 3714201, Batch 0004706362, and Production Date 04/25/2012. Class I Product has the potential to be contaminated with Salmonella. International Flavors & Fragrances, Inc
Food Nat Flavor Beef Marrow, IFF Code: ULL681883, Net Weight 50 lb, Batch 0004684926, Production Date 04/25/2012, For Manufacturing Use Only. IFF Code: ULL681883, Batch 0004684926, and Production Date 04/25/2012. Class I Product has the potential to be contaminated with Salmonella. International Flavors & Fragrances, Inc
Food Nat Flv Beef FF, IFF Code 13580894, Net Weight 50 lb, Batch 0004702577, Production Date 04/23/2012, For Manufacturing Use Only. IFF Code 13580894, Batch 0004702577, and Production Date 04/23/2012. Class I Product has the potential to be contaminated with Salmonella. International Flavors & Fragrances, Inc
Food Beef, IFF code: SN418156, Net Weight 50 lb, Batch 0004714076, Production date 04/23/2012, For Manufacturing use only. IFF code: SN418156, Batch 0004714076, and Production date 04/23/2012. Class I Product has the potential to be contaminated with Salmonella. International Flavors & Fragrances, Inc
Food Nat Beef FF, Iff Code ULL89721, Net Weight 50 Lb, Batch 0004696310, Production Date 04/23/2012, For Manufacturing Use Only. Iff Code ULL89721, Batch 0004696310 and Production Date 04/23/2012 Class I Product has the potential to be contaminated with Salmonella. International Flavors & Fragrances, Inc
Food Bean Sauce Seasoning, IFF Code: 76185, Net Weight 25 lb, Production date:04/26/2012, For Manufacturing use only. Batch: 0004711598, Production date 04/26/2012, Iff Code 76185. Class I Product has the potential to be contaminated with Salmonella. International Flavors & Fragrances, Inc
Biologics Fresh Frozen Plasma (Apheresis) W036511136444; Class III Blood product, collected from a donor whose donor records failed answers to follow-up questions regarding vaccinations, was distributed LifeShare Blood Centers
Food Dannon Activia LIGHT Nonfat Yogurt Peach Flavor 4x4oz cups INGREDIENTS: CULTURED GRADE A NONFAT MILK, WATER, PEACHES ***DISTRIBUTED BY: THE DANNON COMPANY, INC. WHITE PLAINS, NY 10603 UPC 36632 02633 Expiration code of DEC 04 2012 MZ UPC 36632 02633 Expiration code of DEC 04 2012 MZ Class II The recalled products may potentially contain metal fragment(s) from a faulty manufacturing part. The Dannon Company, Inc - Discovery & Innovation Center
Food Dannon Activia LIGHT Nonfat Yogurt Strawberry / Blueberry Flavor 12-4oz cups STRAWBERRY INGREDIENTS: CULTURED GRADE A NON FAT MILK, STRAWBERRIES***BLUEBERRY INGREDIENTS: CULTURED GRADE A NON FAT MILK, BLUEBERRY PUREE***DISTRIBUTED BY THE DANNON COMPANY, WHITE PLAINS, NY 10603***UPC 36632 03581 Expiration code of DEC 05 2012 MZ UPC 36632 03581 Expiration code of DEC 05 2012 MZ Class II The recalled products may potentially contain metal fragment(s) from a faulty manufacturing part. The Dannon Company, Inc - Discovery & Innovation Center
Food Dannon Light & Fit Carb & Sugar Control Cultured Dairy Snack Vanilla Flavor 4x4oz cups UPC 36632 00427 Expiration code of NOV 25 2012 MZ Class II The recalled products may potentially contain metal fragment(s) from a faulty manufacturing part. The Dannon Company, Inc - Discovery & Innovation Center
Devices Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test. Lot numbers FA3085, exp 2013-03-26; and FA3316, exp 2013-11-12 Class II Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR Flex(R) lot FA3085. Quality Control (QC) materials have not exhibited low recovery of the same magnitude. Internal method regression testing versus LC/MS has shown an average 25% low bias compared to LC/MS across the assay range. Individual patients, particularly samples with lower TACR values (e.g., less than 5 ng/mL [6.5 nmol/L]), may show a more appreciable difference due to the typical precision of each methodology. Siemens Healthcare Diagnostics, Inc.
Biologics Red Blood Cells W036812573302; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036812846256; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Blood and Blood Products for Reprocessing W036812573302; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced W089812451534-B Class II Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. Inova Health Care Services, Inova Blood Donor Services
Biologics Platelets Pheresis Leukocytes Reduced Irradiated units W0397126643919 - part 1, W0397126643919 - part 2 Class II Blood products, labeled leukoreduced but which did not meet the requirements for leukoreduced products, were distributed. Aurora Area Blood Bank Dba Heartland Blood Centers
Biologics Red Blood Cells W039708027666D Class II Blood product, incorrectly determined to be negative for the Fyb antigen, was distributed. Aurora Area Blood Bank Dba Heartland Blood Centers
Biologics Red Blood Cells Leukocytes Reduced W089812604806; Class III Blood product, collected from a donor whose hemoglobin was not recorded during donor screening, was distributed. Inova Health Care Services, Inova Blood Donor Services
Biologics Blood and Blood Products for Reprocessing W051512030854; Class II Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed. Memorial Blood Centers
Biologics Red Blood Cells W051512030854; Class II Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed. Memorial Blood Centers
Biologics Source Plasma 12MTNB8646; 12MTNB8318; 12MTNB8074; 12MTNB7755; 12MTNB7400; 12MTNB7164; 12MTNB6681; Class II Blood products, collected from a donor who received a body piercing within 12 months of donating, were distributed. Plasma Biological Services Inc
Biologics Source Plasma TT0297632; TT0302949; TT0305187; Class III Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed. DCI Biologicals Temple Terrace, LLC
Biologics Red Blood Cells W036811257066; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Cryoprecipitated AHF, Pooled W036811823806; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Blood and Blood Products for Reprocessing W036811257066; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics MTS A/B/D Monoclonal and Reverse Grouping Cards (Catalog # MTS080515) and MTS A/B Monoclonal Grouping Cards (Catalog # MTS080017) 06061205703; 07031203730; 07031203732; 07031203734; 07031203735; 07031203736; 09131203702; 09131203706 Class II In-vitro diagnostic test cards, associated with complaints of an incomplete foil seal for specific lots of ID-Micro Typing System Gel Cards, were distributed. Micro Typing Systems, Inc.
Biologics MTS Anti-IgG Cards (Catalog # MTS084024) 08071200124; 08071200125; 08071200126; 08071200127; 08071200128; 08071200129; 08071200130; 08071200131; 08071200132; 08071200133; 08071200136; 09061200101; 09061200103 Class III In-vitro diagnostic test cards, associated with complaints of an incomplete foil seal for specific lots of ID-Micro Typing System Gel Cards, were distributed. Micro Typing Systems, Inc.
Biologics Red Blood Cells W067112099190; Class II Blood products, collected from a donor whose suitability was not adequately determined, were distributed. Blood Center Hammond Laboratory (the)
Biologics Fresh Frozen Plasma W067112099190; Class II Blood products, collected from a donor whose suitability was not adequately determined, were distributed. Blood Center Hammond Laboratory (the)
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W037912178437; Class II Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed. LifeServe Blood Center
Biologics Fresh Frozen Plasma (Apheresis) W089812008471; Class III Blood product, collected from a donor for whom there was no documentation on the donor record of an arm inspection, general appearance of the donor or hemoglobin screening, was distributed. Inova Health Care Services, Inova Blood Donor Services
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W089812008471; Class III Blood product, collected from a donor for whom there was no documentation on the donor record of an arm inspection, general appearance of the donor or hemoglobin screening, was distributed. Inova Health Care Services, Inova Blood Donor Services
Biologics Red Blood Cells Leukocytes Reduced W040712234087; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Indiana Blood Center
Biologics Red Blood Cells Leukocytes Reduced W038612360535; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Suncoast Communities Blood Bank, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W118812517147A; W118812517147B; Class II Blood products, which did not meet the acceptable product specifications, were distributed. The Blood Alliance, Inc.
Biologics Fresh Frozen Plasma W037712024689; Class II Blood product, collected from a donor whose health history was not adequately performed, was distributed. Hoxworth Blood Center UC Medical Center
Biologics Red Blood Cells Leukocytes Reduced W045012026100; Class II Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed. Community Blood Center Of Gtr KC
Biologics Cryoprecipitated AHF, Pooled W045012600486; Class II Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed. Community Blood Center Of Gtr KC
Devices Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical Technique,0612-89-510 Sigma HP Instruments Balanced Surgical Technique, 0612-88-510 Sigma HP Instruments Fixed Reference Surgical Technique, 0612-87-510 PFC Sigma Knee Systems Primary Cruciate-Retaining & Cruciate-Substituting Procedure Surgical Technique,SP2-007 Product Usage: The SP2 IM Rod is used in both primary and revision Sigma knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with the IM tibial resection. This rod is included in both the SP2 and HP instrument kits. Product Code 96-6120 Label code / Etch code C3JHN4 H0808 C3JHS4 H0908 C3JHF4 H1008 C4GA54 C4GCC4 C4GBT4 C52F74 H1108 C52GV4 H1208 C52GL4 C67N14 C98CS4 H0109 C98BF4 DE5P34 H0309 DE5RP4 DF4H44 DG9LK4 H0409 DG9L64 DJ5E34 DK3E34 H0509 DK3FE4 EB5FV4 H0210 D95AN4 EB5GH4 H0310 EC9JY4 EF4DJ4 EJ7AP4 H0410 ES2G64 H0510 EJ7A34 ES2HA4 H0610 ES2HY4 H0710 EX5L44 EX5MS4 H0810 E2SD44 H0910 FA4G94 H0211 FD8MP4 H0311 FH8JA4 FH8JX4 H0611 TBACC TBACC TBACZ TBACZ FJ4E74 TBAGG Class II Potential for the IM rod to break, leaving fragments in the patient. Surgical Techniques guidance has been updated until design changes can be made to reduce likelihood of potential failure. DePuy Orthopaedics, Inc.
Biologics Blood Grouping Reagent, Anti-e (Monoclonal) SEB382A Class III Blood Grouping Reagent Anti-e (Monoclonal) BioClone, with potential of false negative results, was distributed. Ortho Clinical Diagnostics Inc
Devices DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. All lots Class II Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck DePuy Spine, Inc.
Devices DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. All lots Class II Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck DePuy Spine, Inc.
Devices DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. All lots Class II Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck DePuy Spine, Inc.
Devices DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. All lots Class II Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck DePuy Spine, Inc.
Biologics Cornea 0804057COD; 0804057COS; 0806022COS; 0806022COD; 0808025COD; 0808025COS; 0808052COD; 0808052COS; 0810073COD; 0810073COS; 0812022COS; 0812022COD; 0905018COD; 0905018COS; 1004080COD; 1004080COSG1; 1004080COSG2; 1005014COD; 1005014COS; 1006028COD; 1006028COS; 1006046CODG1; 1006046CODG2; 1006046COS; 1007046COD; 1007046COS Class II Human Corneal tissues, recovered from donors and not tested using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. Florida Lions Eye Bank, Inc.
Biologics Cornea 1005010CODG1, 1005010CODG2, 1005010COSG1, 1005010COSG2, 1005010SODW, 1005010SOSW Class III Human Corneal tissues, recovered from donors and not tested using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. Florida Lions Eye Bank, Inc.
Drugs Carisoprodol Tablets, USP, 350 mg Rx Only, 100 tablets per bottle, Rx Only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724, NDC 0143-1176-01. Lot #: 69160A Class III Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Register making this product a schedule IV (C-IV)controlled substance. This product is being recalled because this controlled product was not relabeled with the required "C-IV" imprint on the label for products distributed after the 06/11/12 deadline. West-ward Pharmaceutical Corp.
Food Pascalite Capsules 100 count white plastic bottle with a screw on top, Pascalite Inc, PO Box 104 Worland, WY 82401 307-347-3872, Dietary Supplement for adults and children over 12 years two capsules daily, each vegi cap (size 00) contains approx. 1/4 tsp pascalite powder. Lot numbers imprinted or hand written include: 2010M; and D10 through 12 with a noted OT,U,V, or W. The code information is found on the bottom of the product. Class II Pascalite is recalling internally used pascalite powder products because they may contain violative levels of lead. Pascalite, Incorporated
Food Pascalite Powder 8 oz, 16 oz, 5 lb, and 25 lb packaged in semitransparent flexible plastic containers with a stick on label. Pascalite Clay Powder, Pascalite Inc, PO Box 104 Worland, WY 82401, 307-347-3872 with directions for use as a Poultice, skin cleanser and softener, deodorant an freshener, dentrifice and oral hygiene, and dietary supplement for adults and children over 6. Lot numbers imprinted or hand written include: 2010M; and D10 through 12 with a noted OT,U,V, or W. The code information is found on the bottom of the product. Class II Pascalite is recalling internally used pascalite powder products because they may contain violative levels of lead. Pascalite, Incorporated
Cosmetics Pascalite tooth powder, contained in a semitransparent flexible 6 oz. bottle with a flip top for dispensing. Lot numbers imprinted or hand written include: 2010M; and D10 through 12 with a noted OT,U,V, or W. The code information is found on the bottom of the product. Class II Pascalite is recalling internally used pascalite powder products because they may contain violative levels of lead. Pascalite, Incorporated
Devices Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of Creatinine in human serum and urine on Beckman Coulter AU analyzers. All Class II The recall was initiated by Beckman Coulter because they are including additional information and instructions in the Creatinine (OSR6x78) IFU and Setting Sheet, relating to calibration stability and quality control frequency to assure product performance. Beckman Coulter Inc.
Devices Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Corrective osteotomies after distal radius malunion. Lot number 7965181 Class II It was discovered that one of the VA-LCP Dorsal Distal Radius Plates was incorrectly etched as Part Number 02.115.431 (110 degree) instead of the correct Part Number 02.115.231 (90 degree). Synthes USA HQ, Inc.
Food Cold-smoked salmon in plastic containers. An example of the labeling follows, however, the "SELL BY:" and "PACK DATE" changes. "0297629 015885 SOCKEYE SALMON LOX TRIM WHOLE FOODS MARKET SALMON, SALT, SUGAR AND NATURAL HARDWOOD SMOKE. CONTAINS: FISH***SELL BY: 02.06.13***PACK DATE: 01.30.13***" There is a light blue water mark behind the ingredient statement that reads: "WHOLE FOODS MARKET" PLU: 97629, UPC: 0297629 015885 Product sold before 1/29/13. Class I The repacked cold-smoked salmon trim was processed on the same day as a surveillance sample was processed, that was found positive for Listeria monocytogenes. Whole Foods Market Pacific NW Distribution Center (PDC)
Food Cream cheese/cold smoked salmon (Gravlox) spread in plastic containers. A sample of product label (SELL BY and PACK DATES may differ): "0295307 014144 LOX & CREAM CHEESE WHOLE FOODS MARKET CCOLD SMOKED SALMON (SALMON, SALT, SUGAR AND NATURAL HARDWOOD SMOKE). CREAM CHEESE (PASTEURIZED MILK AND CREAM, CHEESE CULTURE, SALT.***SELL BY 02.06.13***PACK DATE: 01.30.13***" There is a light blue water mark behind the ingredient statement that reads: "WHOLE FOODS MARKET" PLU: 95307, UPC: 0295307 014144 Product sold before 1/29/13. Class I Cold-smoked salmon trim, used to manufacture this cream cheese spread, was processed the same day as a surveillance sample was processed, that was found positive for Listeria monocytogenes. Whole Foods Market Pacific NW Distribution Center (PDC)
Food Whole bagels and half bagels w/ cream cheese/cold smoked salmon spread wrapped in plastic. An example of the whole bagel label (in part): "0298437 003996 BAGEL FULL LOX CREAM CHEESE CAPERS BAGEL (ORGANIC WHEAT FLOUR, ORGANIC WHITE WHOLE WHEAT FLOUR, ORGANIC SUGAR, ORGANIC WHEAT GLUTEN, ORGANIC WHOLE WHEAT FLOUR, ORGANIC OAT FLOUR, YEAST, SALT, ORGANIC OAT FIBER, ORGANIC HIGH***SELL BY: 02.02.13***PACK DATE: 01.30.13***Whole Foods Market Inc., Bellevue, WA 98005***" There is a light blue water mark behind the ingredient statement that reads: "WHOLE FOODS MARKET" An example of the half bagel label (in part): "0292811 001998 HALF BAGEL WITH LOX CAPERS AND CREAM CHEESE CAPERS BAGEL (ORGANIC WHEAT FLOUR, ORGANIC WHITE WHOLE WHEAT FLOUR, ORGANIC SUGAR, ORGANIC WHEAT GLUTEN, ORGANIC WHOLE WHEAT FLOUR, ORGANIC OAT FLOUR, YEAST, SALT, ORGANIC OAT FIBER, ORGANIC HIGH OELIC SUNFLOWER OIL, ORGANIC RAISIN JUICE CONCENTRATE, ORGANIC BARLEY FLOUR, ORGANIC GUAR GUM, ORGANIC CULTURED WHEAT***SELL BY: 02.02.13***PACK DATE: 01.30.13***" There is a light blue water mark behind the ingredient statement that reads: "WHOLE FOODS MARKET" Half Bagel: PLU 92811, UPC: "0292811 001998 Whole Bagel: PLU: 98437, UPC 0298437 003996 All products sold before 1/29/13. Class I Cold-smoked salmon trim, used to manufacture these bagels, processed the same day as a surveillance sample was processed that was found positive for Listeria monocytogenes. Whole Foods Market Pacific NW Distribution Center (PDC)
Devices ReClaim Reamer Extension; Product code 2975-00-500, used with Reclaim Modular Revision Hip Prosthesis System. The ReClaim Reamer Extension is as an attachment to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal. Engraved Lot Number/ Label Lot Number J0111 / 578910 578913 R578910 R578912 R578913 In Kit # 2975-50-025 J0211/ In Kit # 2975-50-025 J0411/ 582631 In Kit # 2975-50-025 J0611/ In Kit # 2975-50-025 J0911/ 592125 In Kit # 2975-50-025 J1211/ 000003583 In Kit # 2975-50-025 NB12649 / NB12649 NB12650 / NB12650 NB12651 / NB12651 NB12652 / NB12652 NB12653/ NB12653 NB12654/ NB12654 NB12655/ NB12655 NB12656/  ...
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Class II DePuy has received 9 complaints where the tabs on the reamer extension device were broken. It was determined to notify surgeons of the issue to increase the awareness and to ask surgeons and users to look for tabs before and after surgery to reduce any potential that the tabs are left in the patient while DePuy investigates the root cause. Once the root cause is determined and a design change is implemented, DePuy will conduct a formal swap-out of the affected devices. DePuy Orthopaedics, Inc.
Drugs Meprobamate, Tablets USP, 200 mg, 100 tablets; Rx only; Manufactured By: Watson Laboratories, Inc., Corona, CA 92800 USA; 173266; . Distributed by: Watson Pharma, Inc., NDC 9591-5239-01 386585A, Exp. 02/13; 429104A, Exp. 06/13; 474487A, Exp. 11/13; 491671A, Exp.01/14. Class II Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone . Watson Laboratories Inc
Drugs Meprobamate; Tablets USP, 400 mg, 100 tablets; Rx only; Manufactured By: Watson Laboratories, Inc., Corona, CA 92800 USA; 173266; . Distributed by: Watson Pharma, Inc., NDC 0591-5238-01 387879A, Exp. 02/13; 429105A, Exp. 06/13; 474488A, Exp. 11/13; 491672A, Exp. 01/14; 529095A, Exp. 04/14 Class II Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone . Watson Laboratories Inc
Devices Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile. Contained in Extremity Medical Surgical Kits including CompressX, Hallu.X, IO Fix and XMCP. Used in the selection of screw size when used with appropriate depth gauge. Catalog Number 101-00006; Lot Number 00921538. Class II The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the measurement reading will not correspond with the desired screw length. The selected screw size based on the depth gauge reading will be about 2 mm longer than intended. Extremity Medical LLC
Drugs ZARAH® Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg, Rx only, 3 tablet dispensers, 28 tablets each, Manuf. by: Watson Laboratories, Inc., Corona, CA 92880. USA; Distributed by: Watson Pharma, Inc., Corona, CA 92880 USA. NDC 52544-981-31 Carton; NDC 52544-981-28 Lot #s: 401536AA/401536A; 401537AA/401537/A; 401538AA/401538/A; 406985AA/406985A; 432058AA/432058A; 512685AA/512685A Class II Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) . Watson Laboratories Inc
Devices 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope. Product Code: V20LC; Lot/Serial Numbers: BB09213 & BB09205 Class III The defect was with mis-engraving of the lot # directly on the product and its packaging. Mixed up device engraving of V20LC (lot # BB09213) with that from V60C (lot # BB09205). Volk Optical Inc
Food Brownberry Healthfull 45 Calories Per Slice Multigrain Bread, 1 LB 2 OZ (510g) Best by dates prior to and including Feb 20 Class II Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products. Bimbo Bakeries Usa
Food Arnold Dutch Country 100% Whole Grain Bread, 1 LB 8 OZ (680g) Best by dates prior to and including Feb 20 Class II Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products. Bimbo Bakeries Usa
Food Brownberry Dutch Country 100% Whole Grain Bread, 1 LB 8 OZ (680g) Best by dates prior to and including Feb 20 Class II Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products. Bimbo Bakeries Usa
Food Arnold Healthfull 45 Calories Per Slice Multigrain Bread, 1 LB 2 OZ (510g) Best by dates prior to and including Feb 20 Class II Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products. Bimbo Bakeries Usa
Food Stroehmann Dutch Country 100% Whole Grain Bread, 1 LB 8 OZ (680g) Best by dates prior to and including Feb 20 Class II Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products. Bimbo Bakeries Usa
Food Aldi L'Oven Fresh Hearty 12 Grain Bread, NET WT 24 OZ (1 LB 8 OZ) 680g Best by dates prior to and including Feb 20 Class II Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products. Bimbo Bakeries Usa
Food Brownberry Healthfull Nutty Grain Bread, 1 LB 8 OZ (680g) Best by dates prior to and including Feb 20 Class II Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products. Bimbo Bakeries Usa
Food Brownberry Grains & More Double Protein Bread, 1 LB 8 OZ (680g) Best by dates prior to and including Feb 20 Class II Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products. Bimbo Bakeries Usa
Food Sara Lee 12 Grain Bread Hearty & Delicious, 24 OZ (1LB 8OZ) 680g Best by dates prior to and including Feb 17 Class II Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products. Bimbo Bakeries Usa
Food Earthgrains 12 Grain Natural Bread, NET WT 1 LB 8 OZ (680g) Best by dates prior to and including Feb 20 Class II Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products. Bimbo Bakeries Usa
Food Farm Bread All Natural Multi-Grain, NET WT 24 OZ (1 LB 8 OZ) 680g Best by dates prior to and including Feb 20 Class II Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products. Bimbo Bakeries Usa
Food Harmons 100% Multi-Grain Wide Pan Oven-Baked Bread, NET WT 24 OZ (1LB 8 OZ) 680g Best by dates prior to and including Feb 20 Class II Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products. Bimbo Bakeries Usa
Food Sara Lee Multi-Grain Thin Style Buns, NET WT 12 OZ (340g) Best by dates prior to and including Feb 17 Class II Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products. Bimbo Bakeries Usa
Food MET-Rx EXTREME NOS PUMPED WATERMELON Naturally and Artificially Flavored DIETARY SUPPLEMENT, 20 FL. OZ. (1.25 PT) (591 mL), UPC 7 49826 27603 8, Label Revision 02C, Item Number 27603 (Bottle) Item Number 27604 (case) --- Manufactured in the USA by MET-Rx Nutrition, Inc. Boca Raton, FL 33487 Lot 460259, exp. 10/31/2013; Lot 464764, exp. 12/31/2013 Class III The color, odor, and taste of the products are changing and do not meet the firm's high quality standards. This is an issue of commercial spoilage. NBTY Inc.
Food MET-Rx EXTREME NOS PUMPED DOUBLE BERRY Naturally and Artificially Flavored DIETARY SUPPLEMENT, 20 FL. OZ. (1.25 PT) (591 mL), UPC 7 49826 35909 0, Label Revision 01C, Item Number 35909 (Bottle) Item Number 35910 (case) --- Manufactured in the USA by MET-Rx Nutrition, Inc. Boca Raton, FL 33487 Lot # 470645, exp. 11/30/2013 Class III The color, odor, and taste of the products are changing and do not meet the firm's high quality standards. This is an issue of commercial spoilage. NBTY Inc.
Food MET-Rx EXTREME NOS PUMPED NITRO-PUNCH Naturally Flavored DIETARY SUPPLEMENT, 20 FL. OZ. (1.25 PT) (591 mL), UPC Code 7 49826 00512 6, Label Revision 05D, Item Number 48515 --- Manufactured in the USA by MET-Rx Nutrition, Inc. Boca Raton, FL 33487 Lot 469477, exp. 11/30/2013 Class III The color, odor, and taste of the products are changing and do not meet the firm's high quality standards. This is an issue of commercial spoilage. NBTY Inc.
Food Great Value All Natural Mild Chunky Salsa, 24 oz (1-lb 8-oz) 680 g.; UPC 007874208639; Distributed by: Wal-Mart Stores, Inc, Bentonville, AR Code Date: 012314 Class II The products may contain plastic pieces. Conagra Inc
Food Great Value Salsa Mild, 16 oz (1lb) 454 g.; UPC 007874212780; Distributed by: Wal-Mart Stores, Inc, Bentonville, AR Code Date:013013 and 020414 Class II The products may contain plastic pieces. Conagra Inc
Food Great Value All Natural Medium Chunky Salsa, 24 oz (1lb 8oz) 680 g.; UPC 007874208640; Distributed by: Wal-Mart Stores, Inc, Bentonville, AR Code Date: 013014 and 020614 Class II The products may contain plastic pieces. Conagra Inc
Food Great Value All Natural Hot Chunky Salsa, 24 oz (1lb 8oz) 680 g.; UPC 0078745208641; Distributed by: Wal-Mart Stores, Inc, Bentonville, AR Code Date: 020514 and 020614 Class II The products may contain plastic pieces. Conagra Inc
Devices INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual. Part #: UM-06-20-0003. ClearStart-SVM is used for patient assessment using CT (computed tomography) images, in order to plan potential therapies or monitor tumor response to treatment. INTIO Inc. Part #: UM-06-20-0003 for SVM User's Manual Class II INTIO Inc. distributed a SVM User's Manual and it has an editing mistake that could be interpreted as promoting an unapproved use. Intio Inc
Devices Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device. Catalog Number 14-500178. Lot numbers: 543619, 543853, 543853-1, 543853-2, 544233, 544234-1, 546613 and 546613-1. Class II Increased risk of failure at the driver tip during screw insertion or removal. Ebi, Llc
Devices Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use in knee prosthesis implantation. NON-STERILE Catalog Number: I-K2401KF00 (note each is uniquely identified/marked as IK2401KF0L and IK2401KF0R - Left and Right). Lot Codes: AP5W52 and AP7H19. Class II The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and that the "R" and "L" markings on the Right Sizer are reversed. Stryker Howmedica Osteonics Corp.
Devices Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508. Catalog # 02-012-42-3508 All lot numbers Class II A dimensional mismatch was identified which can potentially allow for interference between devices. Exactech, Inc.
Devices Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing. Lot numbers: 80106 and 80106b Class II The recalled product leaks at the connection site. Molded Products Inc
Drugs METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 (NDC 0409-7811-24) Lot code 12-074-JT Exp 12/13 Class II Lack of Assurance of Sterility: There is the potential for the solution to leak from the administrative port to the fill tube seal. Hospira Inc.
Food NuGo Free Trail Mix Bars, UPC 6 91535 45301 2 B12233A, best by 20 No 13 Class I NuGo became aware of the possible inadvertent presence of milk in the NuGo Free Trail Mix Bar. NuGo Nutrition HQ
Food Heartland, AMERICA'S ORIGINAL, Harvest Spice Granola Cereal, NET WT 14 OZ. (397g), UPC 024300090394 Best if used by dates: 20130326 (March 26, 2013) - 20130910 (September 10, 2013) Class II Blue Planet products that contain the two recalled Dakota Specialty Milling ingredients; distribution of recalled bulk, wholesale, and cereal items. Blue Planet Foods, Inc.
Food Heartland, AMERICA'S ORIGINAL, Fruit & Nut Harvest Granola Cereal, NET WT 14 OZ. (397g), UPC 024300090387 Best if used by dates: 20130325 (March 25, 2013) - 20130910 (September 10, 2013) Class II Blue Planet products that contain the two recalled Dakota Specialty Milling ingredients; distribution of recalled bulk, wholesale, and cereal items. Blue Planet Foods, Inc.
Food Trio shipper which includes two of the recalled products: Heartland, AMERICA'S ORIGINAL, Harvest Spice Granola Cereal, NET WT 14 OZ. (397g), UPC 024300090394 and Heartland, AMERICA'S ORIGINAL, Fruit & Nut Harvest Granola Cereal, NET WT 14 OZ. (397g), UPC 024300090387 Best if used by dates: UPC 024300090394: 20130326 (March 26, 2013) - 20130910 (September 10, 2013) and UPC 0240300090387: 20130325 (March 25, 2013) - 20130910 (September 10, 2013) Class II Blue Planet products that contain the two recalled Dakota Specialty Milling ingredients; distribution of recalled bulk, wholesale, and cereal items. Blue Planet Foods, Inc.
Food Hannaford Autumn Spice Granola, UPC 041268186327, NET WT. 14 OZ (397g) codes: 20130806 11096071 and 20130813 11156072 Class II Blue Planet products that contain the two recalled Dakota Specialty Milling ingredients; distribution of recalled bulk, wholesale, and cereal items. Blue Planet Foods, Inc.
Food #38605020 ORTH TRANSMART(TM) PRE-BAKED CRISP TOPPING, NET WEIGHT 30 LBS. (13.6 kg) codes: 20130706 07116051, 20130707 07126051, 20130801 08056052, 20130801 08056053, 20130801 08066051, 20130802 08066052, 20130810 08146053, 20130811 08166051, 20130812 08176051, 20130815 08196051, 20130830 09036052, 20130831 09046053, 20130901 09066051, 20130930 10046052, 20130930 10046053, 20130930 10056051, 20131003 10076052, 20131012 10166052, 20131012 10166052, 20131013 10176052, 20131014 10186052, 20131103 11086051, 20131109 11136052, 20131109 11146051, 20131208  ...
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Class II Blue Planet products that contain the two recalled Dakota Specialty Milling ingredients; distribution of recalled bulk, wholesale, and cereal items. Blue Planet Foods, Inc.
Food 10310 CRANBERRY ALMOND GRANOLA, 4/48 OZ. codes: 20130707 10106071, 20130720 10236071, 20131012 01146072, 20131012 01146072 Class II Blue Planet products that contain the two recalled Dakota Specialty Milling ingredients; distribution of recalled bulk, wholesale, and cereal items. Blue Planet Foods, Inc.
Food Blue Planet, 10311 9 Grain Granola, NET WEIGHT 900 lbs (bulk product) codes: 20121127 07306021, 20130212 10156021, 20130219 10226021, 20130313 11126023, 20130402 12036021, 20130403 12036022, 20130416 12166022, 20130426 12266022, 20130507 01066023, 20130515 01156021, 20130522 01216022, 20130528 01286021, 20130529 01286022, 20130110 10226021 Class II Blue Planet products that contain the two recalled Dakota Specialty Milling ingredients; distribution of recalled bulk, wholesale, and cereal items. Blue Planet Foods, Inc.
Veterinary Sogeval Oxiderm +PS Shampoo (Benzoyl Peroxide 3%, Sulfur 2%, Salicylic Acid 2%, PhytoSphingosine 0.05%) Antiseborrheic and Antiseptic Shampoo in a Moisturizing and Soap-Free Cleaning Base 16oz. - For topical use in dogs, cats and horses. Lot # 10690B Product code # FSOXYPS1016 Class III Product contains approximately 12 ounces instead of 16 ounces. Sogeval Laboratories, Inc.
Devices Allen Traction Boot - Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders, non-invasive medical devices designed to attach to orthopedic fracture tables to aid clinical staff in applying traction to the leg of a patient during surgical procedures. A260264, A253312, A260989, A260262, 418292, A260991, A260998, A253313, A260993, A260265, 418293, A253309, A260995, A253310, A260992, A253311, 418294, A253323, A260261, A253321, A260994, 418291, 418295, A253322 Class II Some units may have been assembled incorrectly which could result in the boot breaking free from the mounting base and allowing the patient's leg to fall. Allen Medical Systems, Inc.
Devices Guardian II and Guardian II NC Hemostasis Valve, Model #'s: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, FH102-50, 8215, 8216, 8241, 8242, 8244, 8272 and 8274. Vascular Solutions Zerusa Limited 209 Business Innovation Centre, NUI Galway, Newcastle Road, Galway, Ireland. Intended to maintain hemostasis during the use of diagnostic/interventional devices during diagnostic/interventional procedures. Lot Number 29132 27295 27403 27660 27660 28050 28247 28247 28247 28247 28820 29133 29836 29836 30126 30579 30582 27658 28246 28246 29132 29132 29132 27658 27658 27658 28041 28041 28041 28048 28048 28245 28245 28245 28818 28818 28818 29131 30238 30580 27659 28049 29132 27294 27402 30582 31020 562784  ...
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Class I Vascular Solutions, Inc., is recalling certain lots of Guardian II and Guardian II NC Hemostasis Valves, due to the risk that air may be introduced into the device which may lead to an air embolism. Vascular Solutions, Inc.
Food Vegi-Fiber Plus; O Trans Fat; only 15.4 Calories; Dietary Supplement; 60 Packets; Scientific formula for Natural Vitality; 15 Vegetable and Fruit Extracts; Newest Japanese Carbohydrate Blocker: Fibersol -2; Each Packet Contains 3.5g of Water-Soluble Dietary Fiber. Manufactured for Wynlife Healthcare, Inc., San Diego, CA 92130. PN 135; Lot #'s: 090336 and 100340 Class II Wynlife healthcare is recalling their All-In-One Probiotics and Vegi-Fiber Plus products due to DEHP contaminated clouding agents. Wynlife Healthcare, Inc.
Food All-In-One Probiotics, K12-BB12-LB3; Dietary Supplement; 30 Packets;Serving size 2 Tablets (1 Packet)l L141/1. Adults take 2 to 4 tablets daily; Children: take 1 to 2 tablets daily (or as directed by your healthcare practitioner. Chew slowly or allow to dissolve in mouth. Manufactured for Wynlife Healthcare, Inc., San Diego, CA 92130. PN 141; Lot #'s: 100521 and 110099 Class II Wynlife healthcare is recalling their All-In-One Probiotics and Vegi-Fiber Plus products due to DEHP contaminated clouding agents. Wynlife Healthcare, Inc.
Devices CR MD1.0 General Set, x-ray imager image plate. Product Usage: Usage: The product is an image plate, contained in an X-Ray cassette, and used to capture images from X-Ray exposures. The cassette with the image plate, once exposed is inserted int he Agfa Digitizer CR 10-X where the image plate is taken out of the cassette and then scanned so that the scanned image can be displayed for viewing. Batch No. A2KQMW Class II The cassettes were shipped with the wrong IP (image plate) size bar code. AGFA Corp.
Drugs Myoflex (trolamine salicylate) 10%, Pain Relieving Cream, a) 2-oz tube, b) 4-oz. tube, OTC. The firm name on the label is Novartis Consumer Health, Inc., Parsippany, NJ 07054. Lot #: a) 10086783, 10088745, 10088746, 10090537, 10093867, 10093868, 10098162, 10098541, 10098542, 10102311, 10109145, 10109146, 10120111, 10122759, and 10122760, Exp 3/13 to 9/14; b) 10086785, 10088747, 10088748, 10090538, 10093869, 10093870, 10098160, 10098161, 10098540, 10099841, 10104146, 10109143, 10109144, 10111501, 10115614, 10120112, 10121759, 10122698, 10122757, and 10122758, Exp 3/13 to 10/14. Class III Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible. Novartis Consumer Health
Drugs Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment, a) 1-oz. tubes (NDC 0067-5812-96), b) 2-oz. tubes (NDC 0067-5812-86), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054. Lot #: a) 10109149, 10111499, 10117160, 10119603, and 10121763, Exp 4/13 to 8/13; b) 10109148, 10112258, 10113806, 10115615, 10117161, 10119604, 10119605, 10121782, and 10122762, Exp 3/13 to 9/13. Class III Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible. Novartis Consumer Health
Drugs 4 way Nasal Decongestant Fast Acting Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2086-05), b) 1-fl. oz. bottles (NDC 0067-2086-01), c) 1.25-fl. oz. bottles (NDC 0067-2086-15), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054. Lot #: a) 10108375, 10108376, 10110025, 10110026, 10115487, 10115488, 10120594, 10120595, 10120596, 10120597, 10120753, 10120754, 10120755, 10127564, and 10127567, Exp 4/13 to 11/13, b) 10107916, 10108368, 10108369, 10108370, 10108371, 10108372, 10108373, 10108374, 10110027, 10110028, 10110029, 10110030, 10110031, 10110032, 10110033, 10115803, 10115804, 10115805, 10115806, 10115807, 10115809, 10115810, 10115812, 10115813, 10115814, 10115815,  ...
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Class III Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible. Novartis Consumer Health
Drugs 4 way Nasal Decongestant Menthol Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2087-05) b) 1-fl. oz. bottles (NDC 0067-2087-01), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054. Lot #: a) 10120598, Exp 7/13; 10127563, Exp 11/13; b) 10107920, 10108362, 10108363, 10108364, 10109881, 10110017, 10110018, 10110019, 10110020, 10120730, 10120731, 10120732, 10120733, 10120734, 10120735, 10120736, 10127556, 10127557, 10127558, and 10127559, Exp 3/13 to 10/13. Class III Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible. Novartis Consumer Health
Drugs 4 way Saline Moisturizing Mist with Eucalyptol & Menthol, 1-fl. oz. bottles, OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054. Lot #: 10107922, 10108365, 10108366, 10108367, 10109874, 10110021, 10110022, 10110023, 10110024, and 10120729, Exp 3/14 to 9/14. Class III Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible. Novartis Consumer Health
Devices Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation instaled with the CAS I/II Absorber. Product Usage: intended for use in the hospital environment and locations not requiring portability. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient-breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. This device is intended for use only by a suitably qualified physician. serial numbers: ABSO-004448, ABSO-004458, ABSO-004459, ABSO-004460, ABSO-004461, ABSO-004462, ABSO-004463, ABSO-004465, ABSO-004466, ABSO-004467, ABSO-004468, ABSO-004469, ABSO-004470, ABSO-004471, ABSO-004472, ABSO-004473, ABSO-004474, ABSO-004475, ABSO-004476, ABSO-004477, ABSO-004478, ABSO-004479, ABSO-004480, ABSO-004481, ABSO-004482, ABSO-004483, ABSO-004487, ABSO-004488, ABSO-004489, ABSO-004490, ABSO-004491, ABSO-004492, ABSO-004493, ABSO-004494, ABSO-004495, ABSO-004497, ABSO-004499, ABSO-004500, ABSO-004503, ABSO-004504, ABSO-004505, ABSO-004506, ABSO-004507, ABSO-004508, ABSO-004510, ABSO-004511, ABSO-004512, ABSO-004513, ABSO-004526,  ...
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Class I A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may cause a condition leading to an increase in the carbon dioxide concentration within the inspired gas being delivered to the patient. Del Mar Reynolds Medical, Ltd.
Devices Boston Scientific/Cameron SQ-RX® Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias. SERIAL NUMBERS A002804 A003105 A001493 A001784 A001981 A003024 A003197 A001609 A001594 A001733 A002291 A002348 A002373 A002195 A002710 A004131 A001942 A002278 A002399 A002402 A001021 A001136 A001104 A001193 A001392 A002093 A002147 A001134 A001155 A001063 A001011 A001102 A001012 A001004 A001058 A001010 A001140 A001093 A001170 A001055 A001185 A001144 A001217 A001215 A001241 A001367 A001377 A001405  ...
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Class II Boston Scientific is conducting a recall on Cameron Health /Boston Scientific subcutaneous defibrillators (S-ICD® System). BS identified a rare condition in which an internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. Should this occur, the defibrillator would not be able to deliver therapy or communicate with the Q-TECH Model 2020 programmer, and would be unable to emit tones or otherwise respond to magnet application. No patient deaths or injuries have been reported as a result of this behavior; affected devices were replaced without the need for emergency medical care. Boston Scientific CRM Corp
Food Rye bread with the following brands: Village Hearth , Rye Cottage Bread, NET WT 24 OZ ( 1 LB 8OZ) (680g) , East Coast Caraway Rye, NET WT 20 OZ (1 LB 4 OZ (567g) , PAN-O-GOLD VILLAGE HEARTH BAKER ST, ST. CLOUD, MN 56302. Cub Foods, Deli Rye, NET WT 16 OZ (1 LB) 454 g, Distributed by SUPERVALU INC., Eden prairie, MN 55344. Essential Everyday, Deli Rye Bread, NET WT 16 OZ (1 LB) 454 g Distributed by Supervalu Inc., Eden Prairie, MN 55344, Flvorite, Deli Rye, NET WT 16 OZ (1 lb) 454 g, Distributed by SUPERVALU INC., Eden prairie, MN 55344. Family Choice, Northern Rye Bread, NET WT 16OZ (1 LB) (454G), Seeded Bye Bread, NET WT 20 OZ (1 LB 4 OZ) (567g), Unseeded Rye Bread, NET WT 20 OZ (1 LB 4 OZ) (567g), PAN-O-GOLD VILLAGE HEARTH BAKER ST, ST. CLOUD, MN 56302. Piggly Wiggly, Rye, Seeded Caraway Rye, NET WT 20 OZ (1LB 4 OZ) 568g., distributed by Piggly Wiggly LLC, Keene, NH 03431. Food Club, Rye, NET WT 16 OZ (1 LB) 454g., Distributed by Topco Associates LLC, 7711 Gross Point Road, Skokie, ILL 60077. Shurfresh, Rye, Seeded Rye, Unseeded Rye, NET WT 16 OZ (1LB) 454g & 20 OZ (1LB 4 OZ) 567g., Distributed by Topco Associates LLC, 7711 Gross Point Road, Skokie, ILL 60077. Feb 12 P1..., Feb 12 P3..., Feb 13 P1..., Feb 13 P3..., Feb 14 P1..., Feb 14 P3..., Feb 15 P1..., Feb 15 P3...,Feb 16 P1..., Feb 16 P3...,Feb 17 P1..., Feb 17 P3..., Feb 18 P1..., Feb 18 P3..., Feb 19 P1...,Feb 19 P3... Class II A recall has been initiated by Pan-O-Gold Baking Co. after they were notified by Dakota Specialty Milling of a potential foreign material (stainless steel wire from disintegrated sifter screen) risk to the rye flour Pan O Gold uses as an ingredient in all of their rye breads. Pan -O- Gold Baking Co
Devices PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework. Lot Number: 12857 Class II Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled Keystone Dental Inc
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