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U.S. Department of Health and Human Services

Enforcement Report - Week of October 10, 2012

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells Leukocytes Reduced LW01187 Class III Blood Products, collected from a donor who received varicella zoster vaccine less than 28 days before donating, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Source Plasma 04IIAB0679, 04IIAB0310, 04IIAB0087 Class II Blood products, collected from a donor who was subsequently deferred after testing positive for anti-HCV, were distributed. BioLife Plasma Services L.P.
Biologics Platelets Pheresis Leukocytes Reduced W045003903458; W045003906734; W045003901056; 9065994; 9081220; 9087572; 9088116; 9093337; 9084560; 9083132; 9091354; 9086849; 9072426; 9095890; 9090624; 9069089; 9072517 Class III Blood products, stored under improper conditions, were distributed. Community Blood Center of Greater Kansas City
Biologics Blood and Blood Products for Reprocessing W045004107030 Class II Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. Community Blood Center of Greater Kansas City
Biologics Red Blood Cells W045005003086; I3920886; W045005006455; W045005006445; W045005003529; W045005003115; W045005003356; W045005006056; W045005006063; W045005005702; W045005006059; W045005005707; W045005010376; IFG21596; IFG21843; IFG21844; W045005901830; W045005901828; W045005005762; W045005010966 Class III Blood products, stored at unacceptable temperatures, were distributed. Community Blood Center Of Gtr KC
Biologics Blood and Blood Products for Reprocessing W045004088676 Class II Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. Community Blood Center of Greater Kansas City
Biologics Red Blood Cells W045005023283 Class III Blood product, stored at unacceptable temperatures, was distributed. Community Blood Center of Greater Kansas City
Biologics Red Blood Cells Leukocytes Reduced 06GX46159 Class II Blood products, collected from a donor who was previously deferred after testing HIV-1/2 repeat reactive, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 06GX46159 Class III Blood products, collected from a donor who was previously deferred after testing HIV-1/2 repeat reactive, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced W045005018374; W045005011570 Class III Blood Products, possible exposed to unacceptable temperatures, were distributed. Community Blood Center of Greater Kansas City
Biologics Source Plasma 6120053442, 6120043181, 6120051422, 6120050821, 6120050300, 6120050014, 6120047372, 6120046804, 6120046168, 6120046011, 6120045275, 6120045028, 6120044540. 6120044313, 6120042420, 6120042213, 6120040730, 6120040492, 6120039991, 6120040951, 6120040354, 6120039959, 6120035621, 6120045544, 6120045544, 6120043214, 6120042474, 6120041053, 6120040873, 6120040122, 6120039254, 6120038595, 6120038364, 6120037874 Class II Blood products, collected from donors whose physical examination documentation was incomplete, were distributed. CSL Plasma, Inc
Biologics Red Blood Cells Leukocytes Reduced GT77849; C73312; Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Mississippi Valley Reg Bld Ctr
Biologics Blood and Blood Products for Reprocessing GT77849; C77312; Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells Leukocytes Reduced GW78214 Class II Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Platelets LM53631 Class III Blood product, collected from a donor with a reactive syphilis screening test (RPR), was distributed. Mississippi Valley Reg Bld Ctr
Biologics Source Plasma 4180295599, 4180293457, 4180292748, 4180291210, 4180290494, 4180288898, 4180287380, 4180286664, 4180285136, 4180283611, 4180282862, 4180281289, 4180280660, 4180279234, 4180277146, 4180274840, 4180274123, 4180272549, 4180270820, 4180270301, 4180269252, 4180251088, 4180250297, 4180248757, 4180248007, 4180246535, 4180245777 Class II Blood products, collected from a donor whose physical examination was incomplete, were distributed. CSL Plasma, Inc
Biologics Red Blood Cells 54KG30772 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Biologics Platelets 54KG30772 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Devices IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy. OneTouch(R) Ping(TM) Glucose Management Systems - Part Numbers 101420-00, 101421-00, 101422-00, 101424-00, 101425-00, 100430-00, 100431-00, 100432-00, 100434-00, 100435-00, 101420-98, 101421-98, 101422-98, 101424-98, and 101425-98; Animas(R) 2020 Insulin Infusion  ...
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Class II Wear of the keypad that may lead to damage such as tearing or peeling of the edge of the keypad from the pump. Animas Corporation
Devices Tabs Professional Monitor, includes one wall bracket, Model 25022. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair. Serial numbers 235388 thru 268275 Class II The monitor may fail to sound an alarm Stanley Security Solutions, Inc.
Devices Tabs Professional Monitor, without wall bracket, Model 25023. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair. Serial numbers 236662 thru 265692 Class II The monitor may fail to sound an alarm Stanley Security Solutions, Inc.
Devices Tabs Professional Monitor, without pull cord or wall bracket, Model 25025. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair. Serial numbers 236920 thru 241732 Class II The monitor may fail to sound an alarm Stanley Security Solutions, Inc.
Devices Tabs Professional Voice + Monitor, includes one wall bracket, Model 25222. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair. Serial numbers 228837 thru 268768 Class II The monitor may fail to sound an alarm Stanley Security Solutions, Inc.
Devices Tabs Professional Voice + Monitor, with wire bracket, Model 25223. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair. Serial numbers 236348 thru 347416 Class II The monitor may fail to sound an alarm Stanley Security Solutions, Inc.
Devices 00789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head Provisional 22mm +3.5 00789502220 VerSys Femoral Head Provisional 22mm -2 00789502230 VerSys Femoral Head Provisional 22mm +3 12/14 Neck Taper The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty. All lots distributed from lot 69998600 (2/20/1996) to present Class II Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (i.e. stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Some reports of intraoperative dislodging of the provisional head have also been received. Fourteen (14) of the complaints allege that the provisional head was left in-vivo after separating from mating components during surgery. Provisional head dislodging may result from a number of combined factors, including patient BMI, patient soft tissue tension, incision size, and mating taper fit of the provisional. Zimmer, Inc.
Devices 00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral Head Provisional 26mm +0 00789502603 VerSys Femoral Head Provisional 26mm +3.5 00789502604 VerSys Femoral Head Provisional 26mm +7 00789502605 VerSys Femoral Head Provisional 26mm +10.5 12/14 Neck Taper The provisional heads replicate final femoral implant geometry y and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty. All lots distributed from lot 69998600 (2/20/1996) to present Class II Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (i.e. stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Some reports of intraoperative dislodging of the provisional head have also been received. Fourteen (14) of the complaints allege that the provisional head was left in-vivo after separating from mating components during surgery. Provisional head dislodging may result from a number of combined factors, including patient BMI, patient soft tissue tension, incision size, and mating taper fit of the provisional. Zimmer, Inc.
Devices 12/14 Neck Taper 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femoral Head Provisional 28mm +0 00789502803 VerSys Femoral Head Provisional 28mm +3.5 00789502804 VerSys Femoral Head Provisional 28mm +7 00789502805 VerSys Femoral Head Provisional 28mm +10.5 12/14 Neck Taper The provisional heads replicate final femoral implant geometery and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty. All lots distributed from lot 69998600 (2/20/1996) to present Class II Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Some reports of intraoperative dislodging of the provisional head have also been received. 13 of the complaints allege that the provisional head was left in-vivo after separating from mating components during surgery. An April 2001 letter was sent to all distributors and operation managers in the US explaining the events. A June 2011 letter was sent to distributors in Canada. Zimmer, Inc.
Devices 12/14 Neck Taper 00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Femoral Head Provisional 32mm +0 00789503203 VerSys Femoral Head Provisional 32mm +3.5 00789503204 VerSys Femoral Head Provisional 32mm +7 00789503205 VerSys Femoral Head Provisional 32mm +10.5 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty. All lots distributed from lot 69998600 (2/20/1996) to present Class II Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Some reports of intraoperative dislodging of the provisional head have also been received. 13 of the complaints allege that the provisional head was left in-vivo after separating from mating components during surgery. An April 2001 letter was sent to all distributors and operation managers in the US explaining the events. A June 2011 letter was sent to distributors in Canada. Zimmer, Inc.
Devices 12/14 Neck Taper 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head Provisional 36mm +0 00789503603 VerSys Femoral Head Provisional 36mm +3.5 00789503604 VerSys Femoral Head Provisional 36mm +7 00789503605 VerSys Femoral Head Provisional 36mm +10.5 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty. All lots distributed from lot 69998600 (2/20/1996) to present Class II Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Some reports of intraoperative dislodging of the provisional head have also been received. 13 of the complaints allege that the provisional head was left in-vivo after separating from mating components during surgery. An April 2001 letter was sent to all distributors and operation managers in the US explaining the events. A June 2011 letter was sent to distributors in Canada. Zimmer, Inc.
Devices 12/14 Neck Taper 00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head Provisional 40mm +0 00789504003 VerSys Femoral Head Provisional 40mm +3.5 00789504004 VerSys Femoral Head Provisional 40mm +7 00789504005 VerSys Femoral Head Provisional 40mm +10.5 MIS Femoral The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty. All lots distributed from lot 69998600 (2/20/1996) to present Class II Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Some reports of intraoperative dislodging of the provisional head have also been received. 13 of the complaints allege that the provisional head was left in-vivo after separating from mating components during surgery. An April 2001 letter was sent to all distributors and operation managers in the US explaining the events. A June 2011 letter was sent to distributors in Canada. Zimmer, Inc.
Devices 00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22 00780302203 MIS 12/14 Slotted Femoral Head Provisional +3.5X22 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty. All lots including lot 78939000 (1/7/2002) to present Class II Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Some reports of intraoperative dislodging of the provisional head have also been received. 13 of the complaints allege that the provisional head was left in-vivo after separating from mating components during surgery. An April 2001 letter was sent to all distributors and operation managers in the US explaining the events. A June 2011 letter was sent to distributors in Canada. Zimmer, Inc.
Devices 00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14 Slotted Femoral Head Provisional +0X26 00780302603 MIS 12/14 Slotted Femoral Head Provisional +3.5X26 00780302604 MIS 12/14 Slotted Femoral Head Provisional +7X26 00780302605 MIS 12/14 Slotted Femoral Head Provisional +10.5X26 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty. All lots including lot 78939000 (1/7/2002) to present Class II Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Some reports of intraoperative dislodging of the provisional head have also been received. 13 of the complaints allege that the provisional head was left in-vivo after separating from mating components during surgery. An April 2001 letter was sent to all distributors and operation managers in the US explaining the events. A June 2011 letter was sent to distributors in Canada. Zimmer, Inc.
Devices 00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14 Slotted Femoral Head Provisional +0X28 00780302803 MIS 12/14 Slotted Femoral Head Provisional +3.5X28 00780302804 MIS 12/14 Slotted Femoral Head Provisional +7X28 00780302805 MIS 12/14 Slotted Femoral Head Provisional +10.5X28 00780302814 MIS 12/14 Slotted Femoral Head Provisional +7X28 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty. All lots including lot 78939000 (1/7/2002) to present Class II Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Some reports of intraoperative dislodging of the provisional head have also been received. 13 of the complaints allege that the provisional head was left in-vivo after separating from mating components during surgery. An April 2001 letter was sent to all distributors and operation managers in the US explaining the events. A June 2011 letter was sent to distributors in Canada. Zimmer, Inc.
Devices 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32 00780303203 MIS 12/14 Slotted Femoral Head Provisional +3.5X32 00780303204 MIS 12/14 Slotted Femoral Head Provisional +7X32 00780303205 MIS 12/14 Slotted Femoral Head Provisional +10.5X32 00780303214 MIS 12/14 Slotted Femoral Head Provisional +7X32 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty. All lots including lot 78939000 (1/7/2002) to present Class II Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Some reports of intraoperative dislodging of the provisional head have also been received. 13 of the complaints allege that the provisional head was left in-vivo after separating from mating components during surgery. An April 2001 letter was sent to all distributors and operation managers in the US explaining the events. A June 2011 letter was sent to distributors in Canada. Zimmer, Inc.
Devices 00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780303603 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780303604 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780303605 MIS 12/14 Slotted Femoral Head Provisional +10.5X36 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780304004 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780304005 MIS 12/14 Slotted Femoral Head Provisional +10.5X36 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty. All lots including lot 78939000 (1/7/2002) to present Class II Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Some reports of intraoperative dislodging of the provisional head have also been received. 13 of the complaints allege that the provisional head was left in-vivo after separating from mating components during surgery. An April 2001 letter was sent to all distributors and operation managers in the US explaining the events. A June 2011 letter was sent to distributors in Canada. Zimmer, Inc.
Devices 00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780303603 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780303604 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780303605 MIS 12/14 Slotted Femoral Head Provisional +10.5X36 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780304004 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780304005 MIS 12/14 Slotted Femoral Head Provisional +10.5X36 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty. All lots including lot 78939000 (1/7/2002) to present Class II Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Some reports of intraoperative dislodging of the provisional head have also been received. 13 of the complaints allege that the provisional head was left in-vivo after separating from mating components during surgery. An April 2001 letter was sent to all distributors and operation managers in the US explaining the events. A June 2011 letter was sent to distributors in Canada. Zimmer, Inc.
Food Luna & Larry's Coconut Bliss Mocha Maca Crunch; UPC 8 96767 00143 1 May 2, 2014 and May 3, 2014 (Best if used by) 41-61 (manufacturing facility federal number) Class II Recent tests show that one lot of the raw material, Casa de Mesquite brand Mesquite Bean flour, has the potential to be contaminated with Bacillus cereus, a spoilage organism which can cause diarrhea, nausea and other symptoms Bliss Unlimited
Devices Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland. The Cone Body Trials simulate the respective Cone Body implants and mate with the stem trials to assist the surgeon in assessing the fit of the proposed Implants. The cone body trials is an assembly of the Body and 8 mm Hex Locking Bolt. The trial stem is attached to the trial Cone body via the distal thread of the Locking bolt. Catalog No. 6278-1-019 Mod Rev 19 mm std cone trial 6278-1-021 Mod Rev 21 mm std cone trial 6278-1-023 Mod Rev 23 mm std cone trial 6278-1-025 Mod Rev 25 mm std cone trial 6278-1-027 Mod Rev 27 mm std cone trial 6278-1-029 Mod Rev 29 mm std cone trial 6278-1-031 Mod Rev 31 mm std cone  ...
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Class II Stryker Orthopaedics has become aware of a burr, or a metal shaving, observed in the internal threaded portion of the Cone Body Trial. The typical size of the shaving observed was 1-2 mm in length and 0.037 mm squared in cross section. Stryker Howmedica Osteonics Corp.
Devices EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination. All associated Serial Numbers Class II It was discovered of several generator failures of the EOS System due to failure of its anode controller board that drives the rotation of the X-ray tube anode. Eos Imaging Inc
Devices MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Minimally Invasive Redution Screw System (MIRS) - Labeling number J11031-A Class II Synthes is initiating a Medical Device Labeling Correction following a detailed review of the current labeling in response to reported complaints. Synthes has identified technique measures and has updated the labeling associated with this system. The labeling reflects updated technique recommendations and emphasizes the importance of avoiding rod mis-alignment. Synthes USA HQ, Inc.
Drugs ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators, 25 Applicators per Carton, Single Use, Latex Free, Applicator is STERILE if package is intact, NDC 54365-400-01. Lot 52894, Product Code: 260400 Class II Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing. Carefusion 213, Llc
Drugs Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-3020-01 Lot: 3018952, Exp 08/12 Class III Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing. Mylan Pharmaceuticals Inc.
Food Furikake (a Japanese rice seasoning of seaweed flakes with toppings/seasonings). JFC Brand Furikake-Seto Fumi, 1.7 oz. Packaged in a clear glass jar with plastic twist lid. Lot code/Best before date of 04.05.2014 (stamped on top of the lid). Class I The firm recalled the product due to undeclared eggs, soybeans, and wheat. UPC/Bar code 0 11152 41464 J F C International Inc
Devices BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source. Catalog numbers: 1810000, 1811273, 1811873, 1810873, 18111073 All possible lot numbers: 8Fr: 09061802, 09070201, 09070201, 09101602, 09120701, 10022602, 10030801, 10060102; 10Fr: 09061801, 09070202, 09120702, 09101603, 10022603, 10030802, 10060905, 10060904, 10060103; 12Fr: 09052901, 09061201, 09120703, 09101604, 10022604, 10030803, 10060104. Class II Invuity is notifying customers to return all obsolete BriteField Illuminated Suction Devices from the field. It has not been distributed since March 2011 as the next generation product was introduced at that time. Invuity, Inc.
Food Sliced White Mushroom, Champ's Mushroom, net wt. 8 oz. The UPC is 0 33383 67600 5. Date Code PO 11AUG2012. Date code is the "packed on" date and product has a 10 days shelf life with the pack on date being day one. Class I Champs 8 oz Sliced White Mushrooms are recalled due to potential contamination of Listeria monocytogenes. Triple B Corporation
Food Champ's Sliced White Mushrooms, 227 g/8 oz, in a styrofoam container with shrink wrap, UPC 0 33383 67600 5. Labeled in part: "CHAMP'S MUSHROOMS Sliced White Mushrooms, Product of Canada, 227g/8 oz, 0 33383 67600 5 KEEP REFRIGERATED Packed on Date is PO 11AUG2012. The Best Before is 22AUG2012. Date code is the packed on date and product has a 10 day shelf life with the pack on date being day one. Class I Product recalled due to potential contamination with Listeria monocytogenes. Spokane Produce, Inc.
Food Dole brand Sliced Mushrooms, Net Wt. 8 OZ. (227G), UPC: 0 33383 67600 5, in a plastic container over-wrapped with plastic film. Labeled in part: Dole Sliced Mushrooms, Distributed by Oakshire Mushroom Sales, LLC under license Kennett Square, PA 19348 1-866-355-2077, Product of Canada "33 6" - represents the week of year plus one day of week. Code is etched on label near "Distributed by" text. Class I Product recalled due to potential contamination of Listeria monocytogenes. Oakshire Mushroom Sales, Llc
Food Cucina Fresca Smoked Tomato Sauce. Product is packaged in a glass jar, net weight 24 oz. The UPC is 8-84337 00522-4 Lot 11002A and 11002B. Code is deciphered as: First digit = Shift; Second, Third, and Fourth digit = Julian date; Fifth digit = Production year Class I Smoked Tomato Sauce was recalled due to undeclared milk. The jars actually contain Cucina Fresca Tomato Vodka Sauce, which contains milk as an ingredient, but was mis-labeled as Smoked Tomato Sauce and the label does not declare milk. Cucina Fresca, Inc.
Food Label reads in part "***OCHO RIOS***Jamaican***Curry***Seasoning***Net Wt. 4 & 8 oz (227 g)***Gold Series***Low Sodium***Extra delicious!***Distributed by :***Ocho Rios International***Miami, Florida 33142***Ingredients: Turmeric,***Fenugreek, Coriander, Cumin***Salt, Anise, Pimento, Garlic***"" Jamaican Curry Seasoning 4 oz: B/B # D2215 (Exp. 4/22/15) Class II Whole wheat not declared on label. Ocho Rios-Miami, Inc.
Food Label reads in part "***OCHO RIOS***Hot***Jamaican***Curry***Gold Series***Extra delicious!***Distributed by :***Ocho Rios International***Miami, Florida 33142***Ingredients: Turmeric,***Fenugreek, Coriander, Cumin, Salt,*** Anise, Pepper, Pimento, Garlic***Degree of "Heat" 4-Hot***" Hot Jamaican Curry 4 oz: B/B # A1414 (Exp. 01/14/14) Hot Jamaican Curry 4 oz: B/B # K1713 (Exp. 11/17/13) Hot Jamaican Curry 8 oz: B/B # E2015 (Exp. 05/20/15) Class II Whole wheat not declared on label. Ocho Rios-Miami, Inc.
Food Label reads in part "***OCHO RIOS***Spicy***Jerk***Curry***Distributed by :***Ocho Rios International***Miami, Florida 33142***Ingredients: Turmeric,***Fenugreek, Coriander, Cumin***Salt,*** Anise, Pepper, Pimento, Garlic***Degree of "Heat" 4-Hot***" Spicy Jerk Curry 4 oz: B/B # K1713 (Exp. 11/17/15) Spicy Jerk Curry 4 oz: B/B # E2015 (Exp. 05/20/15) Class II Whole wheat not declared on label. Ocho Rios-Miami, Inc.
Food Label reads in part "***OCHO RIOS***Mild***Jerk***Curry***Seasoning***Extra delicious!***Distributed by :***Ocho Rios International***Miami, Florida 33142***Ingredients: Turmeric,Allspice***Coriander, Fenugreek, Salt, Pepper,***Cumin, Garlic, Onion, Nutmeg,***Cinnamon, Thyme and spices***Degree of "Heat" 2 Mild"***" Mild Jerk Curry Seasoning 4 oz: B/B E1413 (Exp. 5/14/13) Class II Whole wheat not declared on label. Ocho Rios-Miami, Inc.
Drugs Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per carton), NDC 57664-135-65, Distributed by: Caraco Pharmaceutical Laboratories, Ltd. Detroit, MI 48202 Affiliate of Sun Pharmaceutical Industries, Inc. Lot: a) 3305.039B, Exp 07/13; b) 3305.039A, Exp 07/13 Class II Crystallization: Presence of crystals of Nimodipine within the capsule solution. Sun Pharmaceutical Industries Inc.
Food Sadie's Salads Egg Salad, 5 lb, 10 lb plastic tubs All product with use by date up to and including September 13, 2012 Class II Product labeling fails to declare allergens (soybean oil) contained in mayonnaise used as a sub-ingredient Sadie's Salads
Food Sadie's Salads Egg-N-Olive Salad, 5 lb, 10 lb plastic tubs All product with use by date up to and including September 13, 2012 Class II Product labeling fails to declare allergen (soybean oil) contained in salad dressing used as a sub-ingredient Sadie's Salads
Food Sadie's Salads Broccoli Salad, 8 lb and 25 lb plastic tubs All product with use by date up to and including September 13, 2012 Class I Product labeling fails to declare allergens (egg, milk, soybean oil) contained in mayonnaise and yellow american cheese used as sub-ingredients (no label) Sadie's Salads
Food Sadie's Salads Old Fashioned Cream Slaw, 5 lb, 10 lb and 30 lb plastic tubs All product with use by date up to and including September 13, 2012 Class I Product labeling fails to declare allergens (egg, soybean oil) contained in mayonnaise used as ingredients Sadie's Salads
Food Sadie's Salads Cole Slaw, 5 lb, 10 lb and 30 lb plastic tubs All product with use by date up to and including September 13, 2012 Class I Product labeling fails to declare allergens (egg, soybean oil) contained in mayonnaise used as ingredients Sadie's Salads
Food Sadie's Salads Red Skin Potato Salad, 5 lb, 10 lb and 30 lb plastic tubs All product with use by date up to and including September 13, 2012 Class I Product labeling fails to declare allergens (eggs, milk, soybean oil) contained in mayonnaise and sour cream used as sub-ingredients Sadie's Salads
Food Sadie's Salads Potato Salad, 5 lb, 10 lb and 30 lb plastic tubs All product with use by date up to and including September 13, 2012 Class II Product labeling fails to declare allergens (soybean oil) contained in salad dressing used as a sub-ingredient Sadie's Salads
Food Sadie's Salads Macaroni Salad, 5 lb, 10 lb and 30 lb plastic tubs All product with use by date up to and including September 13, 2012 Class II Product labeling fails to declare allergens (wheat, soybean oil, FD&C Yellow #5) contained in the macaroni, salad dressing and pickle relish used as sub-ingredients Sadie's Salads
Food Sadie's Salads Macaroni and Cheese, 5 lb and 10 lb plastic tubs All product with use by date up to and including September 13, 2012 Class II Product labeling fails to declare allergens (wheat and milk) contained in the macaroni and cheese used as sub-ingredients Sadie's Salads
Food Sadie's Salads No Sugar Vegetable Pasta Salad, 4 lb and 8 lb plastic tubs All product with use by date up to and including September 13, 2012 Class II Product labeling fails to declare allergen (wheat) contained in the rotini used as a sub-ingredient Sadie's Salads
Food Wawa Mango Net Wt. 8 oz (227 g) Distributed by Wawa, Inc. Wawa, PA 19063 UPC 726191069267 Lot numbers 226, 227, 228, 229, 230, 232, 233, 234, 235, 236, 237 Product number 10305 Expiration Date 08/19/12 08/20/12 08/21/12 08/22/12 08/23/12 08/25/12 08/26/12 08/27/12 08/28/12 08/29/12 08/30/12 Class I Taylor Farms New Jersey is voluntarily recalling specific code dates of the following products due to containing Daniella Brand mangoes or potentially being processed on common equipment with the Daniella Brand mangoes. since Daniella Brand mangoes were identified by the CFIA as having the potential to be contaminated with Salmonella Braenderup, and are subject to a prior recall posted by CFIA and FDA. Taylor Farms, Inc.
Food Wawa pineapples, strawberries & mango Net. Wt. 9 oz. rigid plastic tray Distributed by: Wawa, Inc. Wawa, PA 19063 UPC 726191061155 Lot numbers 226, 227, 228, 229 Expiration Dates 08/19/12, 08/20/12, 08/21/12, 08/22/12 Class I Taylor Farms New Jersey is voluntarily recalling specific code dates of the following products due to containing Daniella Brand mangoes or potentially being processed on common equipment with the Daniella Brand mangoes since Daniella Brand mangoes were identified by the CFIA as having the potential to be contaminated with Salmonella Braenderup, and are subject to a prior recall posted by CFIA and FDA. Taylor Farms, Inc.
Food Wawa pineapple Net Wt. 7 oz (198 g) rigid plastic tray Distributed by: Wawa, Inc. Wawa, PA 19063 UPC 726191069328 Lot 226, 227, 228, 229, 230, 232, 233, 234, 235, 236, 237 Product number 10303 Expiration Dates 8/19/12, 8/20/12, 8/21/12, 8/22/12, 8/23/12, 8/25/12, 8/26/12, 8/27/12, 8/28/12, 8/29/12, 8/30/12 Class I Taylor Farms New Jersey is voluntarily recalling specific code dates of the following products due to containing Daniella Brand mangoes or potentially being processed on common equipment with the Daniella Brand mangoes since Daniella Brand mangoes were identified by the CFIA as having the potential to be contaminated with Salmonella Braenderup, and are subject to a prior recall posted by CFIA and FDA. Taylor Farms, Inc.
Food Wawa melon mix Net Wt 11 oz (312 g) in rigid plastic trays Distributed by: Wawa, Inc. Wawa, PA 19063 UPC 726191061148 Lot Numbers 226, 227, 228, 229, 230, 232, 233, 234, 235, 236, 237 Product Code 10308 Expiration Dates 08/19/12, 08/20/12, 08/21/12, 08/22/12, 08/23/12, 08/25/12, 08/26/12, 08/27/12, 08/28/12, 08/29/12, 08/30/12 Class I Taylor Farms New Jersey is voluntarily recalling specific code dates of the following products due to containing Daniella Brand mangoes or potentially being processed on common equipment with the Daniella Brand mangoes since Daniella Brand mangoes were identified by the CFIA as having the potential to be contaminated with Salmonella Braenderup, and are subject to a prior recall posted by CFIA and FDA. Taylor Farms, Inc.
Food Wawa Large mixed fruit Net Wt 12 oz (340 g) in rigid plastic trays Distributed by: Wawa, Inc. Wawa, PA 19063 UPC 726191069250. Wawa Small mixed fruit Net Wt 7.5 oz (213 g) in rigid plastic trays Distributed by: Wawa, Inc. Wawa, PA 19063 UPC 726191069243 Large: Lot # 226, 227, 228, 229, 230, 232, 233, 234, 235, 236, 237. Product Code 10307. Expiration Dates 08/19/12, 08/20/12, 08/21/12, 08/22/12,  ...
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Class I Taylor Farms New Jersey is voluntarily recalling specific code dates of the following products due to containing Daniella Brand mangoes or potentially being processed on common equipment with the Daniella Brand mangoes since Daniella Brand mangoes were identified by the CFIA as having the potential to be contaminated with Salmonella Braenderup, and are subject to a prior recall posted by CFIA and FDA. Taylor Farms, Inc.
Food Wawa watermelon Net Wt 8 oz (227 g) in rigid plastic trays Distributed by: Wawa, Inc. Wawa, PA 19063 UPC 726191069274 Lot Numbers 226, 227, 228, 229, 230, 232, 233, 234, 235, 236, 237 Product Code 10302 Expiration Dates 08/19/12, 08/20/12, 08/21/12, 08/22/12, 08/23/12, 08/25/12, 08/26/12, 08/27/12, 08/28/12, 08/29/12, 08/30/12 Class I Taylor Farms New Jersey is voluntarily recalling specific code dates of the following products due to containing Daniella Brand mangoes or potentially being processed on common equipment with the Daniella Brand mangoes since Daniella Brand mangoes were identified by the CFIA as having the potential to be contaminated with Salmonella Braenderup, and are subject to a prior recall posted by CFIA and FDA. Taylor Farms, Inc.
Food Wawa mixed fruit with kiwi Net Wt 9.7 oz (275 g) in rigid plastic trays Distributed by: Wawa, Inc. Wawa, PA 19063 UPC 726191069304 Lot Numbers 226, 227, 228, 229, 230, 232, 233 Product Code 10311 Expiration Dates 08/19/12, 08/20/12, 08/21/12, 08/22/12, 08/23/12, 08/25/12, 08/26/12, 08/27/12 Class I Taylor Farms New Jersey is voluntarily recalling specific code dates of the following products due to containing Daniella Brand mangoes or potentially being processed on common equipment with the Daniella Brand mangoes since Daniella Brand mangoes were identified by the CFIA as having the potential to be contaminated with Salmonella Braenderup, and are subject to a prior recall posted by CFIA and FDA. Taylor Farms, Inc.
Food Wawa mango and yogurt parfait Wt 7.5 oz (213 g) in rigid plastic trays Distributed by: Wawa, Inc. Wawa, PA 19063 UPC 726191070751 Lot Numbers 226, 227, 228, 229, 230, 232, 233, 234, 235, 236, 237 Product Code 10301 Expiration Dates 08/23/12, 08/24/12, 08/25/12, 08/26/12, 08/27/12, 08/29/12, 08/30/12, 09/01/12, 09/02/12, 09/03/12 Class I Taylor Farms New Jersey is voluntarily recalling specific code dates of the following products due to containing Daniella Brand mangoes or potentially being processed on common equipment with the Daniella Brand mangoes since Daniella Brand mangoes were identified by the CFIA as having the potential to be contaminated with Salmonella Braenderup, and are subject to a prior recall posted by CFIA and FDA. Taylor Farms, Inc.
Devices Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds. part number 84635400182, serial numbers E000146 through E002039, (all serial numbers) Class II Accuro has received reports of some Apex Pumps either failing to operate or malfunctioning, at times without notifying the user of such failure or malfunction on the unit's display screen. Accuro Medical Product LLC
Food VA Kit New Gourmet Fruit Salad 7.75#. Item # 70006, UPC is 0 20728 70006 8. Label reads in part "***VA KIT NEW GOURMET FRUIT SALAD 7.75# *** Ingredients: INGREDIENTS: Watermelon, Honeydew, Cantaloupe, Mangos, Kiwi, Blue Berries. *** Pacific Coast Fruit Portland, OR 97232 ***". Best if Used By July 26 to August 30. Class I Daniella brand mangos are recalled because they may be contaminated with Salmonella. Pacific Coast Fruit Company
Food Mango & Cucumber Salsa item # 71784 UPC 0 20728 71784 4, Best if Used By July 30 to September 2; Label reads in part "***MANGO 7 CUCUMBER SALSA ***Ingredients: Mangos, English Cucumber, Pineapple Vinaigrette: Vinegar (Cider, Distilled), Water, Soybean Oil, High Fructose corn Syrup, Brown Sugar, Honey, Dijon Mustard (Water, Mustard Seed, Vinegar, Salt, White Wine, Citric Acid, Tartaric Acid, Spices), Corn Syrup, Mango Puree, Pineapple Juice Concentrate, Tomato Paste, Sugar, Salt Mustard Flour, Xanthan Gum, Garlic Powder, Onion Powder, Spices, Chipotle Peppers, Red Bell Peppers, Potassium Sorbate and Calcium Disodium EDTA used to Protect Quality, Molasses, Color Added, Tamarind, Natural Flavor, Red Bell Pepper, Shallots, Jalapeno Peppers, Cilantro. CONTAINS: SOY. *** Pacific Coast Fruit Portland, OR 97232***" Best if Used By July 30 to September 3 Class I Daniella brand mangos are recalled because they may be contaminated with Salmonella. Pacific Coast Fruit Company
Devices Optilock 2.7 mm Screw Inserter. Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone. The System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, particularly in osteopenic bone. The OptiLock VL Distal Radius Plating System is intended for use in distal radius and ulna (and other small bones), including use in osteopenic bone. Catalog number: 14-400795; and lot numbers: 133420, 409460, 469960, 487650, 487660, 627940, 627950, 797190, and 797200. Class II Field complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properly mate ("lock") into some of the specified screw heads. Drivers near MMC (Maximum Material Condition) or that are misshapen may not properly mate with screws at MMC. Design dimensions and tolerances of the drivers are not properly specified to prevent an incorrect fit between the drivers and the screws in all material conditions. The supplier did not manufacture the instruments to the same degree of geometrical accuracy as prior supplier. It was found that both the supplier and Biomet were not correctly using the "No-Stick" gauge. Biomet, Inc.
Devices Optilock T15 AO Driver (3.5mm). Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone. The System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, particularly in osteopenic bone. The OptiLock VL Distal Radius Plating System is intended for use in distal radius and ulna (and other small bones), including use in osteopenic bone. Catalog number: 36505; and lot numbers: 069540, 179190, 201610, 385380, 419940, 427530, 440360, 440370, 555370, 638560, 645820, and 956960. Class II Field complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properly mate ("lock") into some of the specified screw heads. Drivers near MMC (Maximum Material Condition) or that are misshapen may not properly mate with screws at MMC. Design dimensions and tolerances of the drivers are not properly specified to prevent an incorrect fit between the drivers and the screws in all material conditions. The supplier did not manufacture the instruments to the same degree of geometrical accuracy as prior supplier. It was found that both the supplier and Biomet were not correctly using the "No-Stick" gauge. Biomet, Inc.
Food Kerry Organic Pure 900, Organic Soy Protein Isolate, Item #722234.454, packaged in 20-kg. bags. The firm name on the label is Kerry China, Shanghai, China. Lot #O4120710 Class I The product may be contaminated with Salmonella. Kerry Foods
Food Mango Peeled Halved and Cored, wrapped in plastic and refrigerated. Distributed by FreshPoint Central California, Turlock, CA WM7990, LM8575, GM8838, GM9132, VM9531, NN0110; LN0393, FN0707 Class I Notified by supplier of recall of Daniella brand mangoes due to potential contamination with Salmonella Braenderup. FreshPoint Central California, Inc.
Food Mango Chunks, 5# tub Distributed by FreshPoint Central California, Turlock, CA JM8266, MM8817, GM8838, PM9441, NN0094, LN0393, XN0763 Class I Notified by supplier of recall of Daniella brand mangoes due to potential contamination with Salmonella Braenderup. FreshPoint Central California, Inc.
Devices Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment. HeartStart XL battery M3516A labeled with Made in Taiwan and an R-2011-12 Date of Manufacture Class II HeartStart XL Defibrillator/Monitor (M4735A) used on a patient when AC power is not in use, with a battery that may fail, the device may shut down unexpectedly without providing the user with a low battery warning message or audible tone. Philips Healthcare Inc.
Food 3/16" Slivered Red Onions, 1/5 lb; 1/4" Slivered Red Onions, 2/5lb, 4/5lb; lot codes: 42RNA3A1235, 22RBC1A1235. Class I Gills Onions is recalling diced and slivered onions because it may be contaminated with Listeria monocytogenes Gills Onions, LLC
Food 1/4" Slivered Yellow Onions, 2/5lb, 4/5lb. 1/8" Slivered Yellow Onions, 2/5lb, 4/5lb. 3/16" Slivered Yellow Onions, 2/5lb, 5/2lb, 4/5lb. 3/8" Slivered Yellow Onions, 2/5 lb. 3/8" Slivered Julienne Yellow Onions, 4/5lb. lot codes: 22YAW1A1235, 22YAN1A1235, 22YAO1B1235, 22YAN1B1235, 22YAV1B1235. Class I Gills Onions is recalling diced and slivered onions because it may be contaminated with Listeria monocytogenes Gills Onions, LLC
Food 1/4" Diced Red Onions, 5lb, 2/5lb, 4/5lb; 3/8" Diced Red Onions, 2/5 lb, 4/5lb; lot codes: 42RNA3A1235, 22RBC1A1235. Class I Gills Onions is recalling diced and slivered onions because it may be contaminated with Listeria monocytogenes Gills Onions, LLC
Food 1/2" Diced Yellow Onions, 2/5lb, 4/5lb, 20lb. 1/4" Diced Yellow Onions, 1/5 lb, 2/5lb, 4/5lb. 1/8" Diced Yellow Onions, 4/5lb. 3/16" Diced Yellow Onions, 4/5lb. 3/8" Diced Yellow Onions, 1/5lb, 2/5lb, 4/5lb. lot codes: 22YAW1A1235, 22YAN1A1235, 22YAO1B1235, 22YAN1B1235, 22YAV1B1235. Class I Gills Onions is recalling diced and slivered onions because it may be contaminated with Listeria monocytogenes Gills Onions, LLC
Devices Cemented Tibial Drill Product Usage: The cemented tibial drill is used to prepare the tibial bone prior to the impaction of the applicable stemmed tibial broach. The cemented tibial drill has engraved lines that are size specific to guide the user as to the depth to insert the drill into the tibial bone. Part 42-5399-018-00, Lots 62034571, 62089766 Class II Zimmer is initiating a recall of the Cemented Tibial Drill for the Zimmer Persona Personalized Knee System due to three reports being received as of August 29. 2012 for tibial cortex perforation during preparation of the tibial bone. The investigation into the reports that have been received found that the perforations are occurring while using the Cemented Tibial Drill. The perforations have occurred in the anterior medial tibial cortex, particularly when preparing for a size E tibial plate. As a result of this investigation, Zimmer is detailing below some important aspects within the surgical technique that mitigate the potential of perforating the tibial cortex. In addition, Zimmer is replacing the current Cemented Tibial Drill with a modified version that has relocated the depth indicators for determining how deep to drill for the different sizes of tibial plates. Concurrent with delivery of this notification, your sales representative is replacing your Cemented Tibial Drill. Zimmer, Inc.
Drugs buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 449 10 7, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-449-10, carton barcode 6373944910. Lot #: 0074583, Exp. Date 03/12 Class III Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point. McKesson Packaging Services
Drugs buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 450 10 3, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-450-10, carton barcode 6373945010. Lot #: 0075375, 0074584, Exp 08/12 Class III Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point. McKesson Packaging Services
Devices COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples. All Serial Numbers Class II The recall was initiated because Beckman Coulter has confirmed that the Coulter PrepPlus may experience intermittant reagent level sense failures where the instrument may not produce a warning that a reagent vial is low or out of reagent. Beckman Coulter Inc.
Devices 8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder. Catalog # 165808, Lot # NGWA1111 Class II The 8 Fr. Bardex All-Silicone Foley Catheter with 3cc balloon had an incorrect inflation volume (10 ml instead of 5 ml) printed on the valve cap. C.R. Bard, Inc., Urological Division
Devices IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System. Lot# M012376 and M101865 Class II The recall was initiated because Beckman Coulter has confirmed customer reports of QC shifts, lot-to-lot variation, and an increase in the percent of patient samples recovering >20 IU/mL using the Lots# M012376 and M101865 of IMMAGE RF reagent. The lots identified for the RF reagent might produce false abnormal results. Beckman Coulter Inc.
Food Fresh Cuts, Pineapple Dices, 2 oz, Best By: SEP/15/12, Lot Number: 243 and 245. Lot numbers: 243 and 245. Class II Possible fermentation. Henderson's Best Fresh-Cuts, LLC
Devices Philips Digital Diagnost with patient carriage Model: 712050 with serial number range from 00 000 00 to 09 000 543. Product Usage: Stationary radiographic System Serial number range (patient carriage) from: 00 000 00 to 09 000 543. Class II Hook does not securely hold the footplate in vertical position, causing the footplate to disengage and may fall on patient or operator Philips Healthcare Inc.
Food Cantaloupes are packed in 6ct, 9ct, 12ct, 15ct, 18ct, cardboard cartons with the DFI Brand. "826 California Westside" is also stamped on outside of the carton. Each cantaloupe also has a DFI brand sticker on it. "826" is the packing date. Class I Cantaloupes were tested by USDA MDP and found to be positive for salmonella. Dfi Marketing Inc
Food E-3 Seasoning/Spice, Part #1690. Product is packaged in a white bucket. Net weight 35 lbs. The product is labeled in parts: "***E-3 SEASONING***NET WT 35 LB***Distributed by Boyd Coffee Company, Portland, OR 97230*** Part # - 1690. Lot # - 94675, 95467, 98145, 98764, 101858, 102489, 106319, 107267, 109189, 109281, 114634, and 116602. Class II sub-ingredients hydrolyzed soy protein and hydrogenated soybean oil were not declared on the finished product label of E-3 Seasoning. Boyd Coffee Co
Veterinary Bil-Jac brand Adult Select Formula Dog Food, 6 lb bags, 4bags/case, bags labled in part ***Manufactured by Kelly Foods Corp, Berlin, MD 21811***UPC 731794001095*** 1792-02 (exp 27 Dec 2013) Class II Dry dog food may contain mold. Kelly Foods Corporation
Devices Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract. Model #00711177; S/N: 52979, 52981, 52982, 53643, 53644, 53891, 53892, 54238 Class II When the outer catheter is either coiled or in a contorted configuration outside of the endoscope and the patient, and excessive force is applied to the handle, the jaws may become inoperable and may become stuck in the open condition. US Endoscopy Group Inc
Devices Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coudé-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder. Total affected product: M16, Lot 120425: 420 cases = 4,200 boxes = 126,000 each. 2017.03 is shown on the product labeling as the expiry date for the product, 4 years and 11 months from the date of packaging. The product, M16, is identified with the following UPC Codes for the individual pouches,  ...
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Class II The firm initiated the product recall because labeling on some of the intermediate boxes of catheters identify the contents to be M16C, a coudé-tip catheters while the actual contents are M16Fr male, 16Fr, straight-tip catheters with the pouch and the case box labeled as M16Fr male, 16Fr, straight-tip catheters. Cure Medical LLC
Devices Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "***GYNEX*** Electrode Handpiece, Foot Activated*** Manufactured for GYNEX***" Gynex catalog number: 950 (Gynex REF 950, Electrode Handpiece) It connects the electrode to the food activated electric generator. Electrodes are used in gynecological procedures, in a physician's office, for cutting to remove tissue and coagulation to control bleeding by the use of high frequency current. Manufacturer's lot number: 54-12-2-21-12. Class III The wrong electrical connector pin was attached to the cord during assembly by the manufacturer. this electrical connector is too big to fit into the port on the foot activated generator. this makes the device unusable. Gynex Corporation
Food Coast Tropical Brand Whole Mangoes, Kent & Keitt's varieties, 10 lb box. The recalled mangos were sold between July 7, and August 30, 2012 and can be identified by the brand sticker along with one of the following numbers: 3114, 4051, 4311, 4584, and 4959 and the words PRODUCT OF MEXICO. Packed in carboard open carton tray. The recalled mangos were sold between July 7, and August 30, 2012 and can be identified by the brand sticker along with one of the following numbers: 3114, 4051, 4311, 4584, and 4959 and the words PRODUCT OF MEXICO. Class I The mangoes, packed at Agricola Daniella, in Sinaloa, Mexico, that have the potential to be contaminated with Salmonella Branderup. Coast Citrus Dist
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