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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Source Plasma GFKWMV;GFKXMW; GFLCNS; GFLDJG; GFLFPV; GFLGJT; GFLHQF; GFLJHW; GFLKKC; GFMDZG; GFMGBS; GFMGTN; GFMHXS; GFMJMT; GFMKHX; GFMMBQ; GFMMWS; GFMPJS; GFMQFC; GFMRMP; GFMSVC; GFMVBP; GFMPDV; GFYBVS; GFYCYF; GFYFDR; GFYGLW; GFYGYN; GFYJFM; GFYJTT; GFYKZL; GFYLYK; GFYNZL; GFZHLG; GFZJGY; GFZKMW; GFZLNH; GFZMJH; GFZNFN; GFZPFH; GFZPVM; GFZQPL; GFZRGV; JBBRWK; JBBZYZ Class III Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. ZLB Bioplasma, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced GN97147 Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Blood Bank Of San Bernardino and Riverside Counties
Biologics Blood and Blood Products for Reprocessing. GN97147 Class III Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Blood Bank Of San Bernardino and Riverside Counties
Biologics Source Plasma 65630051; 65624203; 65634226, Class III Blood products collected from a donor who was previously permanently, were distributed. CSL Plasma Inc
Biologics Red Blood Cells Leukocytes Reduced 1669388 (Part A) Class II Blood products, collected from a donor taking the medication Azathioprine, were distributed. Hoxworth Blood Center University of Cincinnati Medical Center
Biologics Fresh Frozen Plasma 1669388 (Part B) Class II Blood products, collected from a donor taking the medication Azathioprine, were distributed. Hoxworth Blood Center University of Cincinnati Medical Center
Biologics Source Plasma 0540484287; 0540483625; 0540483261; 0540482451; 0540482200; 0540481553; 0540481206 Class II Blood products, collected from a donor with a history of incarceration, were distributed. ZLB Bioplasma, Inc.
Biologics Red Blood Cells W001606000743; W001606701171 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Department of the Air Force
Biologics Red Blood Cells Leukocytes Reduced GW84439 Class II Blood product, which did not have the required volume of red blood cells, was distributed. Tri-counties Blood Bank
Biologics Red Blood Cells Leukocytes Reduced 106681705 Class II Blood product, in which routine testing was performed, interpreted and/or documented incorrectly, was distributed. Creative Testing Solutions
Biologics Source Plasma 4020119034 Class II Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. ZLB Bioplasma, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated GW90414 Class II Blood product, which did not meet the acceptable product specifications, was distributed. Tri-counties Blood Bank
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced LT22661 Class III Blood product, which was outside the acceptable quality control ranges, was distributed. Tri-counties Blood Bank
Biologics Red Blood Cells Leukocytes Reduced 2311657 (Part B) Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Central Kentucky Blood Center Inc
Biologics Red Blood Cells Leukocytes Reduced Irradiated GP20788 Class II Blood products, collected from a donor who warranted deferral due to travel to a malaria endemic area, were distributed. Blood Bank Of San Bernardino And Riverside Counties
Biologics Source Plasma 05CILB7848 Class II Blood product, which tested negative for viral markers, but was collected from a donor who subsequently tested positive for hepatitis B surface antigen (HBsAg), was distributed. BioLife Plasma Services L.P.
Biologics Cryoprecipitated AHF GX66980 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Fresh Frozen Plasma GZ12807; GZ07733; GZ01265 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Red Blood Cells Leukocytes Reduced GZ12807; GZ07733; GZ03746; GZ01265; GX91592; GX73202; GX66980 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Cryoprecipitated AHF, Pooled G06089 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Plasma Frozen Cryoprecipitated Reduced GX73202 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Blood and Blood Products for Reprocessing GZ03746; GX91592; GX66980 Class III Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced FZ83288; FZ83288 Class II Blood products, released from quarantine prior to post leukoreduction, were distributed. Tri-counties Blood Bank
Biologics Platelets Pheresis Leukocytes Reduced LY26329; LY26329; LT54308; LT54308 Class II Blood Products, which were contaminated with Corynebacterium species, were distributed. Tri-counties Blood Bank
Biologics Red Blood Cells Leukocytes Reduced LT53144; LT53148; LT53135 Class III Blood products, without any coolant in the shipping container, were distributed. Tri-counties Blood Bank
Biologics Red Blood Cells Leukocytes Reduced 007FJ96470; 007FJ96486; 007FQ47632; 007FY69895; 007GT00703 Class II Blood products, collected from a donor whose suitability to donate were not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W142808202624; W142808202624; W142808202626; W142808202626 Class II Blood products, which did not meet the acceptable product specifications, were distributed. Tri-counties Blood Bank
Biologics Red Blood Cells GE40780; GJ43610 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Southern California Permanente Medical Group Blood Donor Center
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W142808302845; W142808302845 Class II Blood products, which did not meet the acceptable product specifications, were distributed. Tri-counties Blood Bank
Biologics Fresh Frozen Plasma 2995677 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Hoxworth Blood Center University of Cincinnati Medical Center
Biologics Platelets Pheresis Leukocytes Reduced 2964991(Part A), 2964991(Part B), 2921257, 2995677(Part A), 2995677(Part B), 3018389(Part A), 3018389(Part B) Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Hoxworth Blood Center University of Cincinnati Medical Center
Biologics AS-3 Red Blood Cells 3018389, 2921257 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Hoxworth Blood Center University of Cincinnati Medical Center
Biologics Red Blood Cells Leukocytes Reduced 2964223; 2949852 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Hoxworth Blood Center University of Cincinnati Medical Center
Biologics Platelets Leukocytes Reduced 2949852 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Hoxworth Blood Center University of Cincinnati Medical Center
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 3006921(Part A); 3006921(Part B) Class II Blood products, collected from a donor taking the medication Proscar, were distributed. Hoxworth Blood Center University of Cincinnati Medical Center
Biologics Source Plasma 4080319226 4080318753 4080316469 4080313795 4080300331 4080297687 4080258643 4080251284 4080250193 4080249518 4080247964 4080247099 4080245763 4080245107 4080243103 4080242441 4080240908 4080240294 4080238911 4080236960 4080235535 4080234863 4080233687 4080232326 4080231293 4080229645 4080228565 4080226946 4080225852 4080225233 4080223440 4080222876 Class II Blood products, collected from a donor whose physical was improperly documented, were distributed. ZLB Bioplasma, Inc.
Biologics Red Blood Cells Leukocytes Reduced W337609001399, W337610001701 Class III Blood products, collected from a donor with polycythemia, were distributed. St. Thomas More Hospital Blood Bank
Biologics Fresh Frozen Plasma W337610001737, W337609001008, W337609001246, W337609001399, W337610001701, W337610001801 Class III Blood products, collected from a donor with polycythemia, were distributed. St. Thomas More Hospital Blood Bank
Devices Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back, surgery syndrome, intractable low back and leg pain. Multiple lots recalled are the ones with supplier's inner battery lots of 326-508 Class II As part of St. Jude Medical's routine tracking and product monitoring, they have received a total of 214 reports, out of 34,617 Eon Mini IPGs, that lost the ability to communicate or recharge due to an inner battery weld issue resulting in loss of pain relief and subsequent explant. Explant surgery, as with any surgery, presents a risk to patient health. Adverse events associated with an unplanned surgery may be comparable to adverse events associated with planned operations, and may include pain, scarring, and infection, as well as complications from anesthesia. Product investigation and analysis conducted by St. Jude Medical as a result of reports of the inability to communicate or recharge the Eon Mini IPG has identified weld cracks in the IPG's inner battery as the cause of this issue. Prior analysis had indicated that moisture was the cause of weld cracking. However, with the occurrence of additional weld cracks, the firm's investigation has determined that the current weld cracks are not attributed to moisture within the battery. Thorough analysis of the cracked batteries and review of the battery manufacturing processes has identified a need to more frequently maintain and replace certain tools during the internal battery welding process by a St. Jude Medical supplier in order to assure complete alignment between the welding apparatus and the battery. It is important to note that the battery is contained within the hermetically-sealed IPG case and cannot leak electrolyte outside the IPG casing. St. Jude Medical
Devices Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation, dehydration, infiltration with intermedium, and the paraffin infiltration of histological tissue specimens. 1) Model ASP6025 120V/50-60 Hz; Serial Numbers: 171, 200, 202, 204, 206, 208, 210, 212, 214, 216, 218, 220, 222, 224, 226, 228, 230, 232, 234, 236, 238, 240, 242, 244, 246, 248, 250, 252, 254, 256, 258, 260, 262, 264, 266, 268, 270, 272, 274, 276, 278, 280, 282, 284, 286, 288, 290, 292, 294; 2) Model ASP6025 230V/50-60 Hz; Serial Numbers: 162, 163, 168, 169, 170, 183, 184, 201, 203, 205, 207, 209, 211, 213, 215, 217, 219, 221, 223, 225, 227, 229, 231, 233, 235, 237, 239, 241, 243, 245, 247, 249, 251, 253, 255, 257, 259, 261, 263, 265, 267, 269, 271, 273, 275, 277, 279, 281, 283, 285, 287, 289, 291, 293, 295, 297, 299, 301, 303, 305, 307, 309, 311, 313, 315, 317, 319, 320, 321, 323, 325, 327, 328, 329, 331, 333, 335, 337, 339 Class II The Instruction for Use 1v9 Ref F and all previous versions specify incorrect dimensions for the Ready To Use (RTU) bottles from other suppliers than Leica. In case of a pressure failure of the device in combination with a bottle with incorrect dimensions, overflow can cause contamination of reagents. Additionally, the current instructions for use does not highlight the importance to check the filling levels of all reagent bottles (RTU and system bottles) prior to every process run. Without this important information, risk of tissue damage or loss is possible. Therefore the missing information will be distributed to all customers by a Field Service Notice. Leica Microsystems, Inc.
Drugs Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet Inc, Riverside, CA Lot# B43N032, Exp 10/15 Class I Marketed Without an Approved NDA/ANDA; product contains analogues of sildenafil and tadalafil which are active pharmaceutical ingredients in FDA-approved drugs used to treat erectile dysfunction (ED) making this product an unapproved new drug. Green Planet Inc
Devices Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree. Product code: BC0524A; All lots manufactured after March 1, 2011 Class II Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps. Acclarent, Inc.
Devices Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree. Product code: BC0724A; All lots manufactured after March 1, 2011 Class II Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps. Acclarent, Inc.
Devices Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree. Product code: BC8524A; All lots manufactured after March 1, 2011 Class II Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps. Acclarent, Inc.
Devices Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of airway tree. Product code: BC1040A; All lots manufactured after March 1, 2011 Class II Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps. Acclarent, Inc.
Devices Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tree. Product code: BC1240A; All lots manufactured after March 1, 2011 Class II Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps. Acclarent, Inc.
Devices Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree. Product code: BC1440A; All lots manufactured after March 1, 2011 Class II Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps. Acclarent, Inc.
Devices Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of airway tree. Product code: BC1640A; All lots manufactured after March 1, 2011 Class II Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps. Acclarent, Inc.
Biologics Red Blood Cells Leukocytes Reduced W03551095306800; Class II Blood products, collected from a donor who was not deferred after testing reactive for HTLV-I/II, were distributed. OneBlood, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036810828093 Class II Blood products, collected from a donor who lived in an area considered endemic for malaria and had a piercing within 12 months of donation, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036811053144 Class II Blood products, collected from a donor who lived in an area considered endemic for malaria and had a piercing within 12 months of donation, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Fresh Frozen Plasma W036811053144 Class II Blood products, collected from a donor who lived in an area considered endemic for malaria and had a piercing within 12 months of donation, were distributed. Community Blood Centers of South Florida, Inc.
Devices Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients 31176, 018652, 018645R, 42011 Class II Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold the 8mm screws are designed for 9mm screws, and the holes that hold the 9mm screws are designated for 8mm screws. SpineFrontier, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W036512129561; W036512129561 Class II Blood products, collected from a donor who had recently visited a malarial endemic region, were distributed. LifeShare Blood Centers
Biologics Red Blood Cells Leukocytes Reduced W036512158305 Class II Blood product, collected from a donor who had recently visited a malarial endemic region, was distributed. LifeShare Blood Centers
Biologics Platelets Pooled Leukocytes Reduced W036812837810; 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 Fresh Frozen Plasma (Apheresis) 2452490; 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 2055025; 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 Red Blood Cells W036812491773; W036810005930; 2452490; 2055025; 2009327; 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 Platelets 2009327; 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 W036812491773; W036810005930; 2055025; 2009327; 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.
Devices S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are used primarily to remove trial instruments that are used to estimate sizes of intervertebral body fusion devices intended to promote fusion. These devices were used in conjunction with lumbar intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients. Lot: 56H26 Class II Malfunction of slap hammer. SpineFrontier, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Washed 032LM04000; Class III Blood product, with a volume significantly higher than the usual and expected amount, was distributed. American National Red Cross (The)
Devices Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. Custom Spine, Inc. 9 Campus Dr. Parsippany, NJ 07054 USA. TEL: 973-808-0019 The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine for pedicular and non-pedicular fixation. Catalog Number 048545; Lot Number L363 Class II On March 28, 2013, Custom Spine, Inc. issued a minor removal of a lot of 18 screws that were found to be out of specification. The screw length was 5 mm shorter in length than the required specification for the screw size. The product is laser marked 8.5mm X 45mm, but its length measured 40mm. Custom Spine, Inc.
Devices uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan Distributed by Wako Diagnostics Wako Life Sciences, Inc. 1025 Terra Bella Ave., Suto A. Mountain View, CA 94043 USA. The product is a single reagent cartridge run on an automated system and each assay performed on a single disposable chip using microfluidic electrophoretic separation. The reagent cartridge contains various buffers and antibodies. TG340, Exp. 11/30/13 Class II Product fails to meet the accuracy at the low end of the measuring range. Wako Life Sciences, Inc.
Biologics Reagent Red Blood Cells V133096 Class III Antibody Screening Cells, misbranded with incorrect Antigen Profile, were distributed. Alba Bioscience Limited
Devices HeartWare Ventricular Assist System For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. US product: Model 1400, 1401US, 1403US, 1404 International: Model 1400, 1401XX, 1407XX, 1408 ALL HEARTWARE CONTROLLER SERIAL NUMBERS Class II Potential to electrostatic discharged (ESD) HeartWare Inc
Drugs Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactured by VistaPharm, Inc., Birmingham, AL 35242. Distributed by Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28092 USA Lot Numbers: 247900, 251000, 256000, 261200, 263600, 266700, 277100, 280300 and 284300. Class II Failed Impurity/Degradation Specification; "Related Compound C" Actavis South Atlantic LLC
Biologics Micro SSP" Allele Specific HLA Class I DNA Typing Tray B*38/39, Catalog Identification: SSPR1-16 Micro SSP" Allele Specific HLA Class I DNA Typing Tray B*38/39 Catalog Identification: SSPR1-16 Article Number: SSP_DNAT_PI Rev 18 Lot number: 002, batches 001-003 510(K) Number : BK960062 Micro SSP" Allele Specific HLA Class I DNA Typing Tray B*38/39 Catalog Identification: SSPR1-16 Article Number: SSP_DNAT_PI Rev 18 Lot number: 002, batches 001-003 Class II Micro SSP Allele Specific HLA Class I DNA Typing Trays (B*38/39), manufactured with an incorrect primer, were distributed. One Lambda Inc
Biologics Cornea 20110009OD, 20110009OS Class III Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. International Sight Restoration, Inc.
Devices AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5841. This system is for in vitro diagnostic use only. Model Numbers: AU5811-01, AU5821-01, AU5831-01, AU5841-01, AU5811-02, AU5821-02, AU5831-02, AU5841-02, AU5811-03, AU5821-03, AU5831-03, AU5841-03, AU5811-04, AU5821-04, AU5831-04, AU5841-04, AU5811-06, AU5821-06, AU5831-06, AU5841-06 Part Numbers: A94906, A94911, A94916, A91921 A94907, A94912, A94917, A94922 A94908, A94913, A94918, A94923 A94909, A94914, A91949, A94924 A94910, A94915, A94920, A94925 Serial Numbers: All Class II The recall was initiated because Beckman Coulter has identified a software error on AU5800 analyzers with the Automation Ready (AR) Sampler Kit. This software error results in the failure of the concentrated wash solution pump to stop, creating an overflow or leak on each analyzer unit. Beckman Coulter Inc.
Drugs Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet. Physician Sample 7 Tablets bottle, Rx only, Mfd by: Novartis Pharma Stein AG, Stein, Switzerland, NDC 0078-9420-07 Lot F1002 - Exp.12/13 Class II Failed Impurities/Degradation Specifications: unspecified degradation product Warner Chilcott US LLC
Food OSKRI, Coconut Bar Dark Chocolate, Net Wt. 1.9 oz ( 53g), UPC 6 66016 30070 3. Ingredients: Coconuts 55%, Rice Syrup, Dark Chocolate 20% ( Sugar, Cocoa Butter, Chocolate, Soy Lecithin, Natural Vanilla). P 1/1/13 to 6/6/13. EXP 7/7/14 to 12/12/14. LOT 001 to 154. Class I OSKRI Corp is recalling Coconut Bar Dark Chocolate, Coconut Bar Dark Chocolate Minis, Fig Dark Chocolate Bars and Almond Dark Chocolate Bars because of undeclared milk. Oskri Corp.
Food OSKRI, Fig Dark Chocolate Bar, Net Wt 1.9 oz (53g) UPC 6 66016 30030 7. Ingredients: Figs 80%, dark chocolate 20% ( sugar, cocoa butter, pure chocolate, soy lecithin, natural vanilla). P 1/1/13 to 6/6/13. EXP 7/7/14 to 12/12/14. LOT 001 to 164. Class I OSKRI Corp is recalling Coconut Bar Dark Chocolate, Coconut Bar Dark Chocolate Minis, Fig Dark Chocolate Bars and Almond Dark Chocolate Bars because of undeclared milk. Oskri Corp.
Food OSKRI, Almond Dark Chocolate Bars, Net Wt 1.9 oz (53g), UPC 6 66016 30042 0. Ingredients: Almonds 32%, Rice syrup, Rice Crisp, Dark Chocolate 10% ( sugar, chocolate liquor, coco butter, soy lecithin, natural vanilla). P 1/1/13 to 6/6/13. EXP 7/7/14 to 12/12/14. LOT 001 to 154. Class I OSKRI Corp is recalling Coconut Bar Dark Chocolate, Coconut Bar Dark Chocolate Minis, Fig Dark Chocolate Bars and Almond Dark Chocolate Bars because of undeclared milk. Oskri Corp.
Food OSKRI, Coconut Bar Dark Chocolate Minis, Net Wt .88 oz (25g), UPC 6 66016 40031. Ingredients: Coconuts , Rice Syrup, Dark Chocolate ( Sugar, Cocoa Liquor,Cocoa Butter, Chocolate, Soy Lecithin, Vanilla). P 1/1/13 to 6/6/13. EXP 7/7/14 to 12/12/14. LOT 001 to 154. Class I OSKRI Corp is recalling Coconut Bar Dark Chocolate, Coconut Bar Dark Chocolate Minis, Fig Dark Chocolate Bars and Almond Dark Chocolate Bars because of undeclared milk. Oskri Corp.
Devices Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product Code MDS200525 EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121°C, 132°C, 134°C and 135°C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours. Affected Biological Indicator Lot No.: S-444 Class II Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims. Steritec Products Mfc. Co., Inc.
Devices Cardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributor Product Code T40360EZ EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121°C, 132°C, 134°C and 135°C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours. Affected Biological Indicator Lot No.: S-444 Class II Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims. Steritec Products Mfc. Co., Inc.
Devices EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121°C, 132°C, 134°C and 135°C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours. Affected Biological Indicator Lot No.: S-444 Class II Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims. Steritec Products Mfc. Co., Inc.
Devices Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395, Distributor Product Code 61301606638 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 and 3 minutes at 135 pre-vacuum steam sterilizers. Affected Biological Indicator Lot No.:121101-447 and 121101-444 Class II Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims. Steritec Products Mfc. Co., Inc.
Devices Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL 395/25, Distributor Product Code 61301606639 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 and 3 minutes at 135 pre-vacuum steam sterilizers. Affected Biological Indicator Lot No.:121101-447 and 121101-444 Class II Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims. Steritec Products Mfc. Co., Inc.
Devices Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product Code PL 298/25, Distributor Product Code SRSP/25 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 1132 (27270 and 3 minutes at 11357275re-vacuum steam sterilizers. Affected Biological Indicator Lot No.:130301 Class II Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims. Steritec Products Mfc. Co., Inc.
Devices Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132°C (270°F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome Affected Biological Indicator Lot No.:130401 Class II Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims. Steritec Products Mfc. Co., Inc.
Devices Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product Code PL 160/A, Distributor Product Code T40311PE SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132°C (270°F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome. Affected Biological Indicator Lot No.:130401 Class II Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims. Steritec Products Mfc. Co., Inc.
Devices Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system Model number 10094200, serial numbers 4024, 4077, 4043 and 4051 Class II Siemens became aware of an unintended behavior when using the Luminos dRF with software version VD10A. The possibility exists that a software error may occur causing the table to tilt into an upright position and may collide with the floor. Four consignees were notified of this recall by Update Instruction XP067/12/S -- all four units have been corrected. Siemens Medical Solutions USA, Inc
Devices Omnicycle Elite; US Importer and Distributor: Accelerated Care Plus, Reno NV. Manufactured by Medica Medizintechnik GmbH, Hochdorf, Germany. The product is indicated for powered exercise equipment intended for medical purposes. Model number A000-533: Serial numbers: 1034-000-00-09033104 1034-000-00-09033107 1034-000-00-09033108 1034-000-00-09033119 1034-000-00-09033120 1034-000-00-09033121 1034-000-00-09033122 1034-000-00-09033132 1034-000-01-09073002 1034-000-01-09073005 1034-000-01-09073018 1034-000-01-09073021 1034-000-01-09073030 1034-000-01-09073123 1034-000-01-09073129 1034-000-01-09073130 1034-000-01-09073134 1034-000-01-09073136 1034-000-01-09073142 1034-000-01-09073146 1034-000-01-09073147 1034-000-01-09090034 1034-000-01-09101119 1034-000-01-09101126 1034-000-01-09101127 1034-000-01-09102107 1034-000-01-09104132 1034-000-01-09105032 1034-000-01-09105039 1034-000-01-09152114 1034-000-01-09152117 1034-000-01-09152120 1034-000-01-09152131 1034-000-01-09162027 1034-000-01-09162034 1034-000-01-09163094 1034-000-01-09163101 1034-000-01-09164098 1034-000-01-09164101 1034-000-01-09164114 1034-000-01-09171128 1034-000-01-09172011 1034-000-01-09172020 1034-000-01-09172021 1034-000-01-09172026 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TT008153008 TT008153010 TT008153024 TT008153027 TT008202012 TT008202013 TT008202015 TT008202020 TT008202026 TT008202027 TT008202030 TT008202042 TT008202046 TT008202053 TT008202060 TT008252039 TT008252050 TT008252052 TT008252057 TT008291015 TT008291017 TT008291021 TT008291023 TT008291025 TT008291026 TT008291034 TT008291037 TT008291038 TT008291043 TT008291047 TT008291052 TT008291055 TT008291056 TT008324100 TT008324119 TT008324120 TT008324123 TT008324134 TT008324142 TT008324146 TT008361104 TT008361113 TT008364005 TT008365029 TT008365033 TT008365038 TT008365041 TT008371047 TT008371048 TT008371051 TT008371067 TT008393111 TT008393113 TT008393119 TT008393124 TT008393125 TT008393128 TT008393132 TT008393133 TT008403043 TT008461061 TT008461067 TT008461075 TT008461077 TT008461088 TT008461107 TT008461109 TT008461115 TT008483066 TT008483073 TT008483077 TT008483078 TT008483087 TT008483094 TT008483099 TT008483106 TT008483108 TT008483117 TT008483121. Class II An anomaly in the firmware that may cause Omnicycle Elite to operate at a speed other than what was previously set when in reverse mode. Accelerated Care Plus Corporation
Food El Campestre Brand Ceviche Mixto, 2/5 lbs bulk containers into 1/10lbs carton. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton. Labeling reads in part:"CEVICHE MIXTO***NET WT..10 LBS***DIST.BY EL CAMPESTRE DIST TEL (562) 505-7247***". Product is not coded with lot numbers. Expiration date 06/01/13 Class I El Campestre initiated this recall due to the following reason: undeclared allergens: eggs, soy, wheat, and crab extract. El Campestre
Food El Campestre Brand Seafood Ranchero. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton. Labeling reads in part:"SEA FOOD RANCHERO***NET WT..10 LBS***DIST.BY EL CAMPESTRE DIST TEL (562) 505-7247***". Product is not coded with lot numbers. Expiration date 06/01/13 Class I El Campestre initiated this recall due to the following reason: undeclared allergens: eggs, soy, wheat, and crab extract. El Campestre
Food El Campestre Brand Ceviche De Basa. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton. Labeling reads in part:"EL CAMPESTRE CEVICHE DE BASA***NET WT.10 LBS***Manufactured by: El Campestre Compton, CA 90221 (310) 764-2461***". Product is not coded with lot numbers. Expiration date 06/01/13 Class III El Campestre initiated this recall due to the following reason: mislabeling: does not contain Basa fish, it contains Swai fish. El Campestre
Food El Campestre Brand Ceviche Mixto De Basa. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton. Labeling reads in part:"EL CAMPESTRE CEVICHE MIXTO DE BASA***NET WT.10 LBS***Manufactured by: El Campestre Compton, CA 90221 (310) 764-2461***". Product is not coded with lot numbers. Expiration date 06/01/13 Class I El Campestre initiated this recall due to the following reason: undeclared allergens: eggs, soy, wheat, and crab extract. El Campestre
Food El Campestre Brand Ceviche De Camaron. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton. Labeling reads in part:"EL CAMPESTRE CEVICHE DE CAMARON***NET WT.10 LBS***Manufactured by: El Campestre Compton, CA 90221 (310) 764-2461***". Product is not coded with lot numbers. Expiration date 06/01/13 Class II El Campestre initiated this recall due to the following reason: mislabeling: Shrimp not listed in English, but the whole shrimp are visible. El Campestre
Food El Campestre Brand Camaron Aquachile. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton. Labeling reads in part:"EL CAMPESTRE CAMARON AGUACHILE***NET WT.10 LBS***Manufactured by: El Campestre Compton, CA 90221 (310) 764-2461***". Product is not coded with lot numbers. Expiration date 06/01/13 Class II El Campestre initiated this recall due to the following reason: shrimp are not listed in English, but the whole shrimp are visible. El Campestre
Devices Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes. Lot No S-444 Manufacture Date 2013 January 21 Expiration Date 2015 January 21; Lot No S-445 Manufacture Date 2013 February 15 Expiration Date 2015 February 15 ; Lot No S-447 Manufacture Date 2013 March 18 Expiration Date 2015 March 18. Class II Mesa EZTest , Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims. Mesa Laboratories, Inc., Bozeman Manufacturing Facility
Devices Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes. Lot No SR-444 Manufacture Date 2013 January 21 Expiration Date 2015 January 21; Lot No SR-445 Manufacture Date 2013 February 15 Expiration Date 2015 February 15. Lot No SR-447 Manufacture Date 2013 March 18 Expiration Date 2015 March 18. Class II Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims. Mesa Laboratories, Inc., Bozeman Manufacturing Facility
Devices Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. Lot #: 52667001 Catalog #: 181-00-04 Class II When torque is applied to the Articulated Driver at the maximum angle, the cross pin may shift out of position, potentially leading to disassembly of the instrument. Exactech, Inc.
Devices AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag AIA-Analyzer Tips are disposable pipette tips packaged in bulk quantities and used on Tosoh Bioscience AIA Analyzers for lab analysis of various immunoassays. The following lots numbers are affected by this recall: 060811, 070111, B11, B11-12/23/2011, B12-02/07/2012, B12-04/30/2012, B12-06/01/2012, B12-08/06/2012, B12-09/05/2012, B12-10/26/2012, and B12-11/27/2012. Class II Visual inspection of the pipette tips indicated that some of the tips were not uniform in size/length which was causing error messages on the analyzers. Tosoh Smd Inc
Food Arm & Hammer Baking Soda a) Net Wt. 1 LB. (454 g) UPC 3320001130 b) Net Wt. 8 oz. (277 g) UPC 3320001110 Church & Dwight, Co. Inc. 469 N. Harrison Street Princeton, NJ 08543-5297 USA Lot FF3153 Lot FF3154 Class II Church and Dwight Co., Inc. has initiated a recall for Sodium Bicarbonate, USP produced by the Old Fort, OH Sodium Bicarbonate Production facility due to metal and other contamination. Church & Dwight Inc
Devices LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur. CATALOG NO. : Part Number: 1987-19-055 and lot numbers:130896, 132131, 132133, 209461, 209466, 219843, 232972, 295965, 310189, 336843, 349283, 352878, 374125, 379089, A1TAR1, A2AGN1, A2AGS1, A2AGT1, A2AGV1, B2VAL1, B43G11, B43G1A, B43G1B, B43G1C, B43G1D, B69HV1, B69HVA, BK1BB1, BW7DX1, BW7DX1A, E3SJD1, and EN4KJ1. In certain documentation, these alphanumeric lot numbers may appear with three zeros at the end (e.g. A1TAR1 may appear as A1TAR1000). Class I The LPS Lower Extremity Dovetail Intercalary component has the potential for fracture of the female component when exposed to certain physiological loads. DePuy Orthopaedics, Inc.
Drugs Belladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets Phenobarbital USP 16.2 mg, Hyoscyamine Sulfate 0.1037 mg, Atropine Sulfate 0.0194 mg, Scopolamine Hydrobromide 0.0065 mg 30-count bottle (NDC 54868-0031-04), Rx only, Repackaged and distributed by Physicians Total Care, Inc. Tulsa, OK 74146. Lot# 6GP2; Exp 10/14 West-Ward Lot /WWCN 67331A Class II Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall. Physicians Total Care, Inc.
Devices syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo® Dynamics system is intended for the acceptance, transfer, display, storage, archive, and manipulation of digital medical images, including quantification and reportgeneration. syngo® Dynamics is not intended to be used for reading mammography images. Model Number: 10091637, 10091805, with serial numbers 85164, 85289, 85296, 85297, 85149, 85116, 85177, 85051, and 85278. Class II Siemens initiate this recall due to a potential issue when using the sDIS matching rules of the syngo Dynamics Information System version 9.5 or VA10A with modality device configured to end study at association close. Images or DICOM SR objects sent from a modality device to syngo Dynamics may not be saved when the modality is configured at syngo Dynamics to end study at association close, and when sDIS matching rules are in effect. The risk is that a study may be missing some of its images and/or DICOM SR objects and there is no indication to the user that images and/or SR objects are missing from the study. Siemens Medical Solutions USA, Inc
Devices The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration. *** 1) List Number 16206, Serial Numbers: 0017234975 , 0017234978 , 0017234979 , 0017234980 , 0017234981 , 0017234982 , 0017234983 , 0017234984 , 0017234985 , 0017234986 , 0017234988 , 0017234991 , 0017234992 , 0017234993 , 0017234994 , 0017234995 , 0017234996 , 0017234997 , 0017234998 , 0017234999 , 0017235001 , 0017235002 , 0017235003 , 0017235004 , 0017235005 , 0017235006 , 0017235007 , 0017235008 , 0017235009 , 0017235010 , 0017235011 , 0017235014 , 0017235015 , 0017235016 , 0017235017 , 0017235018 , 0017235019 , 0017235020 , 0017235021 , 0017235022 , 0017235023 , 0017235024 , 0017235025 , 0017235026 , 0017235028 , 0017235029 , 0017235030 , 0017235031 , 0017235032 , 0017235033 , 0017235034 , 0017235035 , 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, 0017334100 , 0017334103 , 0017334104 , 0017334106 , 0017334110 , 0017334113 , 0017334114 , 0017334118 , 0017334119 , 0017334126 , 0017334127 , 0017334130 , 0017334132 , 0017334134 , 0017334137 , 0017334152 , 0017334159 , 0017334165 , 0017334479 , 0017334560 Class II The devices secondary audio signal fails to activate. Hospira Inc.
Devices BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # 446257 and 24 test\kit, Catalog # 446252; kits are labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle Sparks, MD 21152 USA, 800-638-8663, www.bd.com/ds*** The Affirm VPIII Microbial Identification Test is a DNA probe test intended for use in the detection and identification of Candida species, Cat #446257: Lot 3035126 Exp 12/04/13 Cat #446252: Lot 3065261 Exp 08/31/13 Class II In vitro diagnostic test kit may exhibit invalid internal negative control results. Becton Dickinson & Co.
Food Fisher's Homestyle Salads LLC***New England Clam Chowder*** packaged in 5 lb and 10 lb plastic containers. No sell-by or expiration date code information was included on the package. A 7-day sell-by date was estimated as 7/4/13. Class II 1) Milk not listed in ingredient statement, but listed in allergen warning statement and as a subingredient of sodium caseinate. 2) Undeclared corn 3) Undeclared crab, lobster and shrimp; allergen statement lists "crustacean shellfish products" Fisher's Homestyle Salads
Food Fisher's Homestyle Salads LLC***Cheddar Potato Soup w/Bacon*** packaged in 5 lb and 10 lb plastic containers. No sell-by or expiration date code information was included on the package. A 10-day sell-by date was estimated as 7/8/13. Class II 1) Milk not listed as source of cream, cheese, or butter 2) Undeclared corn Fisher's Homestyle Salads
Food Fisher's Homestyle Salads LLC***Broccoli Cheese Soup*** packaged in 5 lb and 10 lb plastic containers. No sell-by or expiration date code information was included on the package. A 10-day sell-by date was estimated as 7/8/13. Class II 1) milk not lsited as source of cream, cheese, or butter Fisher's Homestyle Salads
Food Fisher's Homestyle Salads LLC***Crab & Shrimp Salad*** packaged in 5 lb and 10 lb plastic containers. No sell-by or expiration date code information was included on the package. A 7-day sell-by date was estimated as 7/4/13. Class II 1) Undeclared corn 2) undeclared whiting, cod, and/or bream; pollock and whitefish listed in ingredient statement 3) undeclared wheat 4) undeclared Red 40 5) undeclared crab - crab in name of product Fisher's Homestyle Salads
Food Fisher's Homestyle Salads LLC***Gourmet Crab Cakes*** packaged in 6-piece (36 oz) and 12-piece (72 oz) styrofoam trays. No sell-by or expiration date code information was included on the package. A 7-day sell-by date was estimated as 7/1/13. Class I 1) undeclared fish 2) undeclared soy lecithin - soy flour listed in ingredient statement 3) undeclared wheat Fisher's Homestyle Salads
Devices GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A single use device intended for the temporary fixation, correction of stabilization of the right femur. The kit consists of intramedullary nail and set screw. The kit is used in combination with lag screw and (distal) locking screws and end cap as well. Catalog Number- 33250400S Catalog Number 33250360S Class II Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails. Stryker Howmedica Osteonics Corp.
Drugs DayQuil Sinex DayTime Sinus Relief (acetaminophen 325 mg and phenylephrine HCl 5 mg) liquicaps and NyQuil Sinex NightTime Sinus Relief (acetaminophen 325 mg, doxylamine succinate 6.25 mg, and phenylephrine HCl 5 mg) liquicaps Combopack, each 48-count liquicaps per carton contains 32 DayQuil Sinex DayTime Liquicaps and 16 NyQuil Sinex NightTime Liquicaps per carton, Made In Canada, Dist. by Procter & Gamble, Cincinnati, OH 45202, UPC 3 23900 01454 1. Lot # 3051171961, Exp 09/14; Brand Code 84855363 Class II Unit Dose Mispackaging: Product packaging defect which could result in code date smearing, incomplete blister card cuts, and missing or incorrectly placed liquicaps within the blisters. Procter & Gamble Co
Food Lehman's Hot Veggie Mix, packaged in 12/16-oz jars per case, distributed by Lehman's, Kidron, OH 44636 Lot 050815 Class III The pH levels of these products are not accurately measured due to the use of outdated buffers and pH levels do not meet process specifications. Ozark Bottling, LLC
Devices Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3. The application stores patient information in a database, and it may analyze and/or display the data in different formats for evaluation by healthcare professionals for informational purposes. Software Versions 5.2 and 5.3 Class II Notes associated with prescription are not printed to the prescription or to the patient chart. Picis Inc.
Devices Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 Indicated for Hooks, Plate/Rods, Rods and Screws when intended to promote fusion of the cervical spine fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix; Axon and Synapse Systems are indicated for the following: -Degenerative Disk Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); -Spondylolisthesis; -Spinal Stenosis; -Fracture/dislocation; -Atlantoaxial fracture with instability; -Occipitocervical dislocation; -Revision of previous cervical spine surgery; and -Tumo Part Number SD389.477, Lot Number 6913900 Class II A complaint was received from the field, that the drill guide was etched incorrectly, 12mm etch instead of 18mm drill guide. The firm identified that this constituted a field action and retrospectively reported this action. Synthes USA HQ, Inc.
Devices Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation. Part Number 390.007, Lot Number 6800599 Class II It was discovered internally that there was a discrepancy between the insert provided with the Tube to Tube Clamp and what was called for in the Bill of Materials. Following a detailed investigation, it was determined that the incorrect insert was used which indicates that the device is MR Safe, when it is actually MR Conditional. Synthes USA HQ, Inc.
Cosmetics LL Bean Balsam Pine Moisturizing Lotion, 16 oz plastic bottle with pump. UPC 5DC6550000 Lot Number: 132 Class II Mold present in lotion. Sunflower Hill
Cosmetics LL Bean Sea Spray Moisturizing Lotion, 16 oz plastic bottle with pump. UPC 5DC6520000 Lot Number: 130 Class II Mold present in lotion. Sunflower Hill
Cosmetics LL Bean Lemon Verbena Hand and Body Lotion, 16 oz plastic bottle with pump. UPC 5DC6560000, Item Number: 5DC6560 N/A Class II Mold present in lotion. Sunflower Hill
Devices ViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients. Serial No. AAAA20120800519 AAAA20120800520 AAAA20120800526 AAAA20120800527 AAAA20120800533 AAAA20120800537 AAAA20120800538 AAAA20120800539 AAAA20120900544 AAAA20120900548 AAAA20120900557 AAAA20120900562 AAAA20120900564 AAAA20120900577 AAAA20120900578 AAAA20120900580 AAAA20120900584 AAAA20120900587 AAAA20120900591 AAAA20130400890 AAAA20130400896 AAAA20130400902 AAAA20130400909 AAAA20120800501 AAAA20121200604 AAAA20121200606 AAAA20121200609 AAAA20121200610 AAAA20121200611 AAAA20121200615 AAAA20121200617 AAAA20121200618 AAAA20121200620 AAAA20121200621 AAAA20121200624 AAAA20121200626 AAAA20121200628 AAAA20121200629 AAAA20121200630 AAAA20121200632 AAAA20121200636 AAAA20121200639 AAAA20121200640 AAAA20121200645 AAAA20121200647 AAAA20130100680 AAAA20130100684 AAAA20130100688 AAAA20130100689 AAAA20130100691 AAAA20130100692 AAAA20130100693 AAAA20130100694 AAAA20130100698 AAAA20130100699 AAAA20130100700 AAAA20130100701 AAAA20130100703 AAAA20121200605 AAAA20121200612 AAAA20121200613 AAAA20121200622 AAAA20121200625 AAAA20121200627 AAAA20121200633 AAAA20121200642 AAAA20121200643 AAAA20121200646 AAAA20121200648 AAAA20121200649 AAAA20121200650 AAAA20121200651 AAAA20121200652 AAAA20121200653 AAAA20130100654 AAAA20130100655 AAAA20130100656 AAAA20130100657 AAAA20130100658 AAAA20130100660 AAAA20130100661 AAAA20130100662 AAAA20130100664 AAAA20130100665 AAAA20130100666 AAAA20130100669 AAAA20130100670 AAAA20130100671 AAAA20130100672 AAAA20130100678 Class II Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound. Sotera Wireless, Inc.
Devices ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients. Serial No. ACBE20120900183 ACBE20120900189 ACBE20120900205 ACBE20120900206 ACBE20121000217 ACBE20121000224 ACBE20121000225 ACBE20121000226 ACBE20121000231 ACBE20121000232 ACBE20121000236 ACBE20121000240 ACBE20121000245 ACBE20121000250 ACBE20121000252 ACBE20121000259 ACBE20121000260 ACBE20121000261 ACBE20121000262 ACBE20121000271 ACBE20121100292 ACBE20121100296 ACBE20121100300 ACBE20130200445 ACBE20120900211 ACBE20121000222 ACBE20121000237 ACBE20121000246 ACBE20121000263 ACBE20121100277 ACBE20121100280 ACBE20121100283 ACBE20121100287 ACBE20121100291 ACBE20121100356 ACBE20121100360 ACBE20121100364 ACBE20130100394 ACBE20130100395 ACBE20130100397 ACBE20130100398 ACBE20130100399 ACBE20130100401 ACBE20130100402 ACBE20130100404 ACBE20130100405 ACBE20130100410 ACBE20130100411 ACBE20130100412 ACBE20130100415 ACBE20130100417 ACBE20121000218 ACBE20121000227 ACBE20121000270 ACBE20121100282 ACBE20121100286 ACBE20121100288 ACBE20121100301 ACBE20121100350 ACBE20121100352 ACBE20121100355 ACBE20130100369 ACBE20130100370 ACBE20130100374 ACBE20130100375 ACBE20130100376 ACBE20130100378 ACBE20130100379 ACBE20130100380 ACBE20130100384 ACBE20130100385 ACBE20130100388 ACBE20130100390 ACBE20130100392 ACBE20130100393 Class II Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound. Sotera Wireless, Inc.
Food Penny's Garlic Hummus 12 oz has UPC 7 49404 83061 4; Harbor Greens Garlic Hummus 8 oz has UPC 7 49404 802123; Tacoma Boys Garlic Hummus 8 oz has UPC 7 49404 902120; The 1 Gallon hummus does not have any brand name and does not have any UPC. USE BY dates 7/13/2013 - 8/25/2013. Class I Garlic Hummus is recalled due to a potential contamination with Listeria monocytogenes. Hagee Foods Inc.
Food PENNY'S CREAMY HUMMUS 12 oz has UPC 7 49404 90971 6; PENNY'S SALSA Creamy Original Hummus 25 LB has no UPC. USE BY dates 7/13/2013 - 8/25/2013. Class I Creamy Hummus is recalled due to a potential contamination with Listeria monocytogenes. Hagee Foods Inc.
Food Penny's Hummus De Gallo 12 oz has UPC 7 49404 32368 0; Harbor Greens Hummus De Gallo 8 oz has UPC 7 49404 8061609; Tacoma Boys Hummus De Gallo 8 oz has UPC 7 49404 90676 6. USE BY dates 7/13/2013 - 8/25/2013. Class I Hummus De Gallo is recalled due to a potential contamination with Listeria monocytogenes. Hagee Foods Inc.
Food Penny's Roasted Red Pepper Hummus 12 oz has UPC 7 49404 51848 2; Harbor Greens Roasted Red Pepper Hummus 8 oz has UPC 7 49404 80414 1; Tacoma Boys Roasted Red Pepper Hummus 8 oz has UPC 7 49404 90414 8; Roasted Red Pepper Hummus (no brand name) 1 gallon has No UPC. USE BY dates 7/13/2013 - 8/25/2013. Class I Roasted Red Pepper Hummus is recalled due to a potential contamination with Listeria monocytogenes. Hagee Foods Inc.
Food Penny's Jalapeno Hummus 12 oz UPC 7 49404 91368 3; Harbor Greens Jalapeno Hummus 8 oz UPC 7 49404 80313 7; Tacoma Boys Jalapeno Hummus 8 oz UPC 7 49404 90313 4. USE BY dates 7/13/2013 - 8/25/2013. Class I Jalapeno Hummus is recalled due to a potential contamination with Listeria monocytogenes. Hagee Foods Inc.
Food Penny's Black Bean Hummus 12 oz has UPC 7 49404 70200 3; Harbor Greens Black Bean Hummus 8 oz has UPC 7 49404 80515 5; Tacoma Boys Black Bean Hummus 8 oz has UPC 7 49404 90515 2. USE BY dates 7/13/2013 - 8/25/2013. Class I Black Bean Hummus is recalled due to a potential contamination with Listeria monocytogenes. Hagee Foods Inc.
Food Harbor Greens Sun-Dried Tomato Hummus 8 oz has UPC 7 49404 80717 3; Tacoma Boys Sun-Dried Tomato Hummus 8 oz has UPC 7 49404 90717 0. USE BY dates 7/13/2013 - 8/25/2013. Class I Sun-Dried Tomatoes Hummus is recalled due to a potential contamination with Listeria monocytogenes. Hagee Foods Inc.
Food Vegetable tray 8 oz UPC 7 49404 98020 3; Ingredients: Carrot Sticks, Celery, Grape Tomatoes, Creamy Hummus. Penny's Salsa Inc. Snack Pack 8 oz has UPC 07494041923606. Ingredient: W/Hummus, Celery, Carrots, Tomato. Both of these products contain the same ingredients in the same amount. The hummus is in a 1.5 oz container, labeled Made in the Pacific North West. USE BY dates 7/13/2013 - 7/24/2013. Class I Vegetable Trays and Snack Pack, 8 oz, are recalled because they contain 1.5 oz cups of hummus. The hummus is recalled due to a potential contamination with Listeria monocytogenes. Hagee Foods Inc.
Food Vegetable tray 8 oz UPC 7 49404 30002 5; Ingredients: Carrot Sticks, Pretzels, Grapes, Creamy Hummus. Penny's Salsa Inc. Snack Pack w/Hummus Grapes, Carrots and Pretzels 8 oz UPC 07494041923679. Both of these products contain the same ingredients in the same amount. Each contains a 1.5 oz package of hummus labeled Made in the Pacific North West. USE BY dates 7/13/2013 - 7/24/2013. Class I Vegetable Trays and Snack Pack, 8 oz, are recalled because they contain 1.5 oz cups of hummus. The hummus is recalled due to a potential contamination with Listeria monocytogenes. Hagee Foods Inc.
Food Pimento Cheese, packaged in 7 oz. plastic containers, and labeled in part ***Made by Whole Foods Market, Landover, MD 20785***UPC: 000000234801 Use by 07/29/13 Class I Pimento cheese was mislabeled with an ingredient list, which did not declare the presence of mayonnaise, containing egg sub-ingredient. Whole Foods Market Mid-Atlantic Kitchen
Devices GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal; Transrectal; and Intraoperative (abdominal, PV and neurological). Mfg Lot or Serial # D16290 D16293 D16294 D16295 D16296 D16297 D16299 D16300 D16301 D16302 D16303 D16304 D16305 D16306 D16309 D16310 D16311 D16312 D16313 D16314 D16315 D16316 D16318 D16319 D16326 D16335 D16336 D16337 D16338 D16339 D16340 D16341 D16342 D16343 D16345 D16346 D16362 D16366 D16367 D16368 D16370 D16371 D16372 D16373 D16374 D16375 D16377 D16378 D16396 D16398 D16399 D16400 D16401 D16402 D16403 D16404 D16405 D16406 D16432 D16433 D16434 D16435 D16436 D16437 D16438 D16439 D16440 D16441 D16453 D16458 D16460 D16461 D16462 D16466 D16467 D16468 D55513 D55514 D55515 D55519 D55520 D55521 D55522 D55538 D55539 D55540 D55541 D55543 D55549 D55550 D55551 D55565 D55566 D55568 D55578 D55579 D55580 D55581 D55582 D55598 D55603 D55605 D55606 D55615 D55616 D55617 D16407 D55524 D04446 D16477 D55516 D55534 D55557 D55588 D16239 D55576 D55623 D55625 D16348 D16349 D16350 D55552 D55553 D55554 D55555 D55560 D16254 D16257 D16257 D55336 D55337 D55338 D55348 D55595 D13829 D15232 D15425 D15973 D16193 D16245 D16248 D16255 D16260 D16262 D16317 D16324 D16334 D16344 D16352 D16358 D16369 D16380 D16384 D16385 D16390 D16393 D16424 D16445 D16448 D16454 D16455 D16464 D16480 D16481 D16482 D16483 D16484 D16486 D16487 D55437 D55517 D55548 D55575 D55593 D55607 D55608 D55611 D55612 D55621 D55624 D55627 D16240 D55518 D55572 D55573 D55574 D55610 D16442 D55510 D55599 D55622 D03382 D16256 D55544 D55629 D05257 D10516 D13472 D15189 D15444 D15454 D16235 D16242 D16244 D16246 D16251 D16264 D16265 D16277 D16279 D16280 D16281 D16284 D16331 D16333 D16347 D16353 D16382 D16387 D16388 D16389 D16409 D16410 D16411 D16412 D16413 D16414 D16415 D16427 D16428 D16429 D16443 D16444 D16449 D16478 D55532 D55556 D55585 D55586 D55587 D00716 D04334 D11004 D15447 D16241 D16258 D16263 D16276 D16286 D16287 D16289 D16291 D16292 D16307 D16327 D16379 D16391 D16408 D16416 D16423 D16425 D16426 D16430 D16488 D55015 D55472 D55525 D55526 D55527 D55528 D55530 D55535 D55542 D55545 D55567 D55589 D55590 D55591 D55592 D55596 D55597 D55632 D55633 D11463 D16250 D16355 D16363 D16364 D16479 D03377 D16288 D16325 D55563 D55601 D00688 D03104 D04391 D05445 D11398 D11419 D13350 D16267 D16269 D16271 D16272 D16273 D16274 D16321 D16322 D16323 D16419 D16420 D16422 D55546 D16236 D16259 D16351 D55561 D16446 D55531 D55630 D16397 D55594 D16332 D16465 D16392 D16261 D16330 D16473 D16475 D55558 D55583 D55584 D16320 D55577 D55602 D55631 D00101 D00853 D16328 D16329 D16470 D03958 D16252 D16361 D55562 D16395 D16472 D55626 D55628 D55414 D55533 D01077 D16243 D16253 D16268 D16308 D16381 D16451 D16463 D55570 D55600 D55634 D16418 D16270 D16282 D16283 D16285 D55559 D16237 D16359 D16365 D16452 D16476 D55571 Class II GE Healthcare has recently become aware that during use of the Voluson E6 or E8 systems, that an error message Out of Memory can be displayed which could cause the system to freeze. This is an intermittent behavior that also requires a certain workflow. This issue can be resolved by rebooting the system. GE Healthcare, LLC
Devices GE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transesophageal, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection. Mfg Lot or Serial # 223133WX0 223134WX8 223135WX5 223136WX3 223137WX1 224634WX6 224635WX3 224636WX1 224637WX9 224638WX7 224639WX5 224640WX3 224641WX1 224642WX9 224643WX7 224644WX5 224645WX2 224786WX4 224787WX2 224788WX0 224789WX8 224790WX6 224791WX4 224792WX2 224793WX0 224794WX8 224795WX5 224796WX3 224797WX1 224798WX9 224799WX7 224800WX3 224801WX1 224802WX9 224803WX7 224804WX5 224805WX2 224806WX0 224807WX8 224808WX6 224951WX4 225010WX8 225011WX6 225012WX4 225013WX2 225014WX0 225015WX7 225143WX7 225144WX5 225145WX2 225146WX0 226933WX0 226934WX8 226935WX5 226936WX3 226937WX1 227218WX5 227219WX3 227221WX9 227222WX7 227223WX5 227224WX3 227225WX0 227226WX8 227227WX6 227228WX4 227229WX2 227230WX0 227231WX8 227232WX6 227233WX4 227279WX7 227280WX5 227281WX3 227282WX1 227283WX9 227284WX7 227285WX4 227286WX2 227287WX0 227288WX8 227574WX1 227575WX8 227576WX6 227577WX4 227578WX2 228256WX4 228257WX2 228258WX0 228259WX8 228260WX6 228772WX0 228773WX8 228774WX6 228775WX3 228776WX1 228777WX9 228778WX7 228779WX5 228780WX3 229786WX9 229787WX7 229790WX1 229791WX9 229792WX7 229793WX5 231677WX6 231678WX4 231679WX2 231680WX0 231681WX8 231682WX6 231683WX4 231684WX2 231685WX9 231686WX7 231687WX5 231688WX3 231689WX1 231690WX9 232467WX1 232468WX9 232470WX5 232471WX3 232472WX1 232473WX9 232474WX7 232500WX9 232501WX7 232502WX5 232503WX3 232504WX1 232505WX8 232506WX6 233383WX9 233384WX7 233385WX4 233386WX2 233387WX0 233388WX8 233389WX6 233390WX4 233391WX2 233392WX0 233393WX8 233394WX6 233395WX3 233396WX1 234475WX2 235601WX2 235602WX0 235603WX8 235604WX6 235605WX3 236395WX0 236396WX8 236397WX6 236398WX4 236399WX2 237120WX1 237121WX9 237122WX7 237123WX5 237124WX3 237617WX6 237618WX4 237619WX2 237620WX0 237621WX8 238640WX7 238641WX5 238642WX3 238643WX1 238644WX9 240405WX1 240406WX9 240407WX7 240408WX5 240409WX3 240410WX1 240411WX9 240412WX7 240413WX5 240414WX3 240415WX0 240416WX8 242064WX4 242065WX1 242070WX1 242071WX9 242073WX5 242074WX3 242075WX0 242076WX8 242077WX6 242078WX4 242499WX2 242500WX7 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228811WX6 228812WX4 228879WX3 228880WX1 228881WX9 228883WX5 229152WX4 229153WX2 229154WX0 229155WX7 229159WX9 229160WX7 229161WX5 231962WX2 231966WX3 231969WX7 231970WX5 231973WX9 231974WX7 231975WX4 231976WX2 231977WX0 231978WX8 233261WX7 233314WX4 233320WX1 233322WX7 234468WX7 234469WX5 234471WX1 234472WX9 234613WX8 234614WX6 234615WX3 234616WX1 234618WX7 234921WX5 234926WX4 235600WX4 235658WX2 235660WX8 235661WX6 235662WX4 235663WX2 235668WX1 235891WX9 235892WX7 235893WX5 235894WX3 235895WX0 237096WX3 237097WX1 237099WX7 237110WX2 237115WX1 237118WX5 237739WX8 237743WX0 237744WX8 237745WX5 237746WX3 238519WX3 238520WX1 238521WX9 224954WX8 226012WX3 226013WX1 226014WX9 226015WX6 226016WX4 226017WX2 226018WX0 226019WX8 226020WX6 226021WX4 226217WX8 226218WX6 226219WX4 226220WX2 226221WX0 226222WX8 226223WX6 226224WX4 226225WX1 226226WX9 227118WX7 227119WX5 227120WX3 227121WX1 227122WX9 227123WX7 227124WX5 227125WX2 227126WX0 227127WX8 227128WX6 227129WX4 227130WX2 227131WX0 227132WX8 227133WX6 227134WX4 227135WX1 227136WX9 227858WX8 231972WX1 233262WX5 233317WX7 233318WX5 237117WX7 237738WX0 237750WX5 237751WX3 237570WX7 241229WX4 241230WX2 226296WX2 226297WX0 226298WX8 226299WX6 226300WX2 228242WX4 228243WX2 228244WX0 228245WX7 228246WX5 232582WX7 234619WX5 235642WX6 237106WX0 237125WX0 238639WX9 239507WX7 239525WX9 239559WX8 239560WX6 240337WX6 240338WX4 240339WX2 240340WX0 240362WX4 240437WX4 240438WX2 241113WX0 241114WX8 241115WX5 241116WX3 241188WX2 227860WX4 227861WX2 227862WX0 228806WX6 231965WX5 231971WX3 233321WX9 234466WX1 234470WX3 234473WX7 234922WX3 234923WX1 234924WX9 235599WX8 237101WX1 227677WX2 227678WX0 227683WX0 227684WX8 227687WX1 227688WX9 228884WX3 228885WX0 228886WX8 229944WX4 229945WX1 229946WX9 229947WX7 229948WX5 232446WX5 232447WX3 232448WX1 232449WX9 232450WX7 232451WX5 232452WX3 233397WX9 233398WX7 233399WX5 233657WX6 233658WX4 233659WX2 233660WX0 234932WX2 234933WX0 235596WX4 235643WX4 235644WX2 235645WX9 236233WX3 236234WX1 236235WX8 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Image data from one patient has the potential to be linked to the patient ID of another patient. GE Healthcare, LLC
Food PERFECT 3000 CHOCOLATE POWDER, FORMULA # 3098. The product is loose powder packaged in bulk drum. Lot BA13032003 Class II Firm had distributed the bulk product in violation of the Consent Decree for Permanent Injunction (12-CV-3468). Kabco Pharmaceuticals, Inc.
Food PERFECT 3000 VANILLA POWDER, FORMULA # 3101. The product is loose powder packaged in bulk drum. Lot BA13032004A and 13032004B Class II Firm had distributed the bulk product in violation of the Consent Decree for Permanent Injunction (12-CV-3468). Kabco Pharmaceuticals, Inc.
Food 10-inch Supreme Chocolate Layered Cake; 12 units per shipping case CMS Item Code: 18238200; Lot Code: 6DA 1316100598 Class II Foreign Material Contamination - Ball point pen CSM Bakery Products North America
Food Hummus is packed in 1.5 oz plastic portion cups with foil peel lids, 100 cups in a case. The product labeled in parts: "***HUMMUS***1.5 oz*** KEEP REFRIGERATED*** BEST BY: 07/20/13 Class I Hummus, 1.5 oz. plastic portion cups with foil peel lids, is recalled due to a potential to be contaminated with Listeria monocytogenes. Northwest Gourmet Food Products, Inc.
Drugs Olanzapine Tablets, USP, 10 mg, Rx Only, 30 tablets per bottle, Mfd for: Prasco Laboratories, Mason OH, 45040, USA, Mfd by: Torrent Pharmaceuticals Ltd., Indrad-382 721, Dist. Mehsana India, NDC 66993-463-30 Lot #: BS392004A, Exp: 09/2014 Class II Defective Container; This action is being taken as a precautionary measure due to the product being re-packaged in the U.S. using a filler material that (removes or blocks) less moisture than what is approved in the application. Torrent Pharma Inc
Drugs DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product L5B4826, NDC 0941-0409-07 Product Code: L5B4826, Lot #: C886820, Exp 11/14 Class II Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed. Baxter Healthcare Corp.
Food WHOLEY Shrimp, Farm Raised, Cooked, Peeled Deveined, Tail on, Ingredients: Shrimp, Salt and Sodium Tripolyphosphate..., ,Net Wt 1 LB (16 oz) , 399103 UPC Number: 094776074556; Product of Indonesia lot No 30081, 10081, 70081, 70084, 30084, and 00884 Class I Lipari Foods of Warren, MI is recalling Wholey peeled, cooked, tail-on 31/40 count shrimp, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Lipari Foods, Inc.
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