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U.S. Department of Health and Human Services

Enforcement Report - Week of April 17, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells Leukocytes Reduced 020LC73053, 020LC74275. Class II Blood products, which were collected from a donor who traveled to malarial endemic areas, were distributed American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 4509454. Class II Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Northwest Florida Blood Center, Inc.
Biologics Cryoprecipitated AHF 11GY34917 Class II Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. American Red Cross Blood Services
Biologics Platelets Pheresis 4079047 Class III Blood product, for which storage condition was outside the acceptable range, was distributed. Northwest Florida Blood Center, Inc.
Biologics Platelets Leukocytes Reduced Irradiated 4920778(B); 4920778(A). Class III Blood products, prepared without the appropriate amount of additive added and/or incorrectly added, were distributed. Northwest Florida Blood Center, Inc.
Biologics Platelets Pheresis Leukocytes Reduced - Triple Product 7725412(Part A); 7725412(Part B); 7725412(Part C); Class II Blood products, which did not meet the acceptable product specifications, were distributed. Suncoast Communities Blood Bank, Inc.
Biologics Red Blood Cells Leukocytes Reduced 03LE38562 Class II Blood product, which was in transit greater than 24 hours, was distributed. American Red Cross Blood Services
Biologics Platelets Pheresis Leukocytes Reduced 21LQ15939, 21LQ15947, 21LQ15950, 21LQ15953, 21LQ15971, 21LQ15992; 21LQ16025, 21LQ16027, 21LQ16042, 21LQ16043, 21LQ16062, 21LQ16064, 21LQ16122, 21LQ16167, 21LQ16190, 21LQ16215, 21LQ16299, 21LQ16314, 21LQ16336, 21LQ16351, 21LQ16446, 21LQ16462, 21LQ16520, 21LQ16530, 21LQ16546, 21LQ16633, 21LQ16648, 21LQ16249, 21LQ16635, 21LQ16637, 21LQ16642, 21LQ16222, 21LQ16305, 21LQ16529, 21LQ16542, 21LQ16552, 21LQ16174, 21LQ16020, 21LQ16186, 21LQ16302, 21LQ16602, 21LQ16113, 21LQ16073, 21LQ16076, 21LQ16137, 21LQ16161, 21LQ16304, 21LQ16084, 21LQ16328, 21LQ15970,  ...
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Class II Blood products, which did not meet acceptable product specifications, were distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 21LQ16150, 21LQ16030, 21LQ16044, 21LQ16076, 21LQ16078, 21LQ16082, 21LQ16179, 21LQ16310, 21LQ16368, 21LQ16501, 21LQ16542, 21LQ16616, 21LQ16623, 21LQ15970, 21LQ16118, 21LQ16598, 21LQ16634, 21LQ16275, 21LQ16637, 21LQ16013, 21LQ16111, 21LQ16142, 21LQ16177, 21LQ16585, 21LQ16593, 21LQ16107, 21LQ16324, 21LQ16450, 21LQ16168, 21LQ16197, 21LQ16469 Class II Blood products, which did not meet acceptable product specifications, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced Washed 8315018 Class II Blood product, which was collected from a donor who traveled to malarial endemic area, was distributed Florida Georgia Blood Alliance, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 4922809 Class III Blood products, which may have been exposed to unacceptable temperature during storage, were distributed. Florida Blood Services, Inc.
Biologics Platelets Pheresis Leukocytes Reduced 4922805 Class III Blood products, which may have been exposed to unacceptable temperature during storage, were distributed. Florida Blood Services, Inc.
Biologics Platelets Pheresis Leukocytes Reduced 020P32286; 020P32289 Class II Blood products, which did not meet acceptable product specifications, were distributed. American National Red Cross (The)
Biologics Cryoprecipitated AHF 31GE08119 Class II Blood products, collected from a donor who was previously deferred, were distributed. American National Red Cross (The)
Biologics Red Blood Cells 31GE03055; 31GE08119 Class II Blood products, collected from a donor who was previously deferred, were distributed. American National Red Cross (The)
Biologics Platelets 31GE08119 Class II Blood products, collected from a donor who was previously deferred, were distributed. American National Red Cross (The)
Biologics Fresh Frozen Plasma 31GE03055 Class II Blood products, collected from a donor who was previously deferred, were distributed. American National Red Cross (The)
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 26GE17710; 26GE17710 Class III Blood products, which failed to meet the minimum specification for product volume, were distributed. The American National Red Cross South Carolina Region
Biologics Platelets Pheresis Leukocytes Reduced 36FJ16721;36FJ16721 Class II Blood products, where quality control and distribution of products did not meet specifications, were distributed. The American National Red Cross South Carolina Region
Biologics Platelets Pheresis Leukocytes Reduced 09FC20679; 09FC20682; 09FC20681; 09FC20687; 09FC20689; 09FC20688; 09FC20686; 09FC20692; 09FC20685; 09FC20683; 09FC20680; FC20691; FC20693; FC20694; FC20695; FC20696; FC20697; FC20698; FC20699; FC20700; FC2070001; FC20702; FC20703; FC20704; FC20705; GL22503; GL22504; GL22505; GL22506; GL22507; GL22508; GL22509; GP27459; GP27462; GP27463; GP27467; GP27468; GP27470; GZ10224; GZ10228 Class III Blood products, in which QC was not performed or unacceptable for West Nile Virus, were distributed. American National Red Cross (The)
Biologics Red Blood Cells-Leukocytes Reduced FM51751; FZ70110; FZ70176; FZ70179; FZ70180; FZ70181; FZ70182; FZ70190; FZ70192; FZ70193; FZ70195; FZ70197; FZ70202; FZ70203; FZ70206; FZ70207; GJ88089; GJ88092; GJ88096; GR12284 Class III Blood products, in which QC was not performed or unacceptable for West Nile Virus, were distributed. American National Red Cross (The)
Biologics Red Blood Cells FS15612; FS15613; FS15614; FS15615; FS15616; FS15617; FZ0183; FZ70186; FZ70187; FZ70188; FZ70191; FZ70201; FZ70208; GR12286 Class III Blood products, in which QC was not performed or unacceptable for West Nile Virus, were distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced Irradiated GP27458; GP27465 Class III Blood products, in which QC was not performed or unacceptable for West Nile Virus, were distributed. American National Red Cross (The)
Biologics Granulocytes Pheresis GP27460 Class III Blood products, in which QC was not performed or unacceptable for West Nile Virus, were distributed. American National Red Cross (The)
Biologics Red Blood Cells 009E19267, 009E19270, 009FF69669, 009FV35905, 009FV35910, 009FV35922, Class III Blood products, for which shipping and storage conditions were undocumented, were distributed. The American National Red Cross South Carolina Region
Biologics Cryoprecipitated AHF 012X44022, 012X44024, 012X44013, 012X44016, 012X43541, 012X44006, 012GY07319, 012X43532, 012GY07315, 012GY07317, 012G07304, 012GY07310, 012E85978, 012FL38709, 012E85972, 012E85975, 012E85970, 012E85971, 012X44018, 012X44021, 012GY07303, 012GY07305, 012FL38043, 012GY07152, 012C82302, 012E85969, 012C82288, 012C82293, 012GY07322, 012K30342, 012K30354, 012K30356, 012K30362, 012K30364, 012L65504 Class III Blood products, for which shipping and storage conditions were undocumented, were distributed. The American National Red Cross South Carolina Region
Biologics Plasma Frozen 012GE97062, 012GE97066, 012GR97068, 012GE97070, 012GK59334, 012GK59341, 012KE11591, 012KE11593, 012KE11602, 012KE11605, 012FZ71992, 012KM26395, 012FY22926, 012FY22929, 012LW25039, 012FK0667, FN25400, 012FQ89358, 012FQ89362, 012FX12666, 012FJ00408, 012FX12671, 012FX12676, 012KE11610, 012KE11611, 012KE11616, 012KP07814 Class III Blood products, for which shipping and storage conditions were undocumented, were distributed. The American National Red Cross South Carolina Region
Biologics Blood and Blood Products for Reprocessing 36FF29709 Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. The American National Red Cross South Carolina Region
Biologics Red Blood Cells Leukocytes Reduced 36FF29709 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. The American National Red Cross South Carolina Region
Biologics Red Blood Cells (Apheresis) W037908108661 Class II Blood products, which did not meet the acceptable product specifications for release, were distributed. LifeServe Blood Center
Biologics Red Blood Cells Leukocytes Reduced 20LE13245. Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American National Red Cross
Biologics Blood and Blood Products for Reprocessing 20LE13245. Class III Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced 36GL21029 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. The American National Red Cross South Carolina Region
Biologics Plasma Frozen 36GL21029 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. The American National Red Cross South Carolina Region
Biologics Source Plasma I52036026;I52036120;I52037633;I52037894;I52038291;I52038528;I52038925;I52039319;I52041067;I52041878;I52042096;I52042895;I52043139;I52044589;I52044752;I52045480;I52045753;I52046240 Class II Blood products, collected from a donor who was permanently deferred, were distributed. Talecris Plasma Resources, Inc.
Devices G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood. 11103403, 11103503, 10942812, 11514801, 11674706, 11313707, 11273006, 10952212, 12266302, 10872910R, 12506812, 11273206, 12678203, 12728404, 12075007, 12205211, 12627811, 12668403, 12708704, 10361310R, 10792008R. Class III Inspectional observations made during establishment inspection include Quality System Regulation deficiencies found that several undocumented and unreported corrections were made to a device. These corrections may constitute changes to the device that may require the submission of a new 510(k). Tosoh Bioscience Inc
Food Giant Eagle Lotsa Chocolate Chip Cookies Lot numbers 073013 and 072313 Class II Labels do not accurately state ingredients/nutrition facts/allergens. An incorrect label was placed on this product that does not declare soy lecithin while the actual product contains soy lecithin. Giant Eagle
Devices Posey Biothane Restraint Cuffs, Catalog Number 2900. The device is intended to limit a patient's movement to the extent necessary for treatment or protection of the patient or others. The model/catalog number for the device is 2900. All lots are being recalled. Class II The firm voluntarily recalled Biothane Restraint Cuffs, Catalog No. 2900, that did not meet the required specifications for tensile strength. Failure of these rivets could allow the cuff to become disconnected from the connecting strap and allow patients to regain free use of the limb. J T Posey Company
Devices Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT). Catalog numbers B4219-1 and B4219-2: lot numbers 547311, exp 3/22/2013; 547312, exp 3/22/2013 and 547316A, exp 4/28/2013. Class II Siemens has observed that the listed lot numbers show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citrol(R) Heparin Control, low and high. Siemens Healthcare Diagnostics, Inc.
Biologics Leukotrap Blood Collection Systems with Flexible Y Connector, labeled as being manufactured by Medsep Corporation, A Subsidiary of Pall Corporation 12092 BLOOD BAG CP2D/AS3 DBL 500 SP; 12193 BLOOD BAG CP2D/AS3 TR500MLSP; 12194 BLOOD BAG CP2D/AS3 QD500MLSP; 12393 RC-PL TRIP CP2D/AS3  ...
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Class II Whole Blood Collection Sets, with a potential for a leak to occur in the flexible Y connector of the donor line, were distributed. Haemonetics Corporation
Devices ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. System No. 10568605:100044 100078 100085 100088 100098 100135 100020 100025 100001 100002 100003 100004 100006 100007 100008 100009 100010 100011 100012 100013 100014 100016 100017 100019 100023 100024 100028 100029 100030 100031 100032 100033 100034 100035 100036 100037 100038 100039 100040 100041 100042 100045 100047 100049 100051 100052 100053 100054 100056 100058 100059 100060 100061 100062 100063 100065 100066 100068 100069 100070 100071 100072 100073 100074 100075 100077 100079 100080 100082 100086 100087 100089 100090 100091 100092 100093 100094 100099 100101 100103 100104 100106 100107 100108 100111 100112 100113 100114 100115 100118 100119 100120 100121 100123 100124 100125 100126 100127 100130 100131 100133 100136 100138 100140. Class II A potential safety risk with the MOSAIQ Oncology Information System that has been identified by the manufacturer IMPAC Medical Systems, Inc. Siemens Medical Solutions USA, Inc
Biologics Red Blood Cells W036812530523; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Blood and Blood Products for Reprocessing W036812530523; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036811822641; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Fresh Frozen Plasma W036811261912; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036811261912; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced W227712080362; Class II Blood products, which were collected from a donor who traveled to malarial endemic area, were distributed. Mid-South Regional Blood Center
Biologics Platelets Pheresis Leukocytes Reduced W221612616122; Class II Blood product, collected that did not have WBC QC testing for contamination, was distributed. Central Texas Regional Blood & Tissue Center
Devices Giraffe OmniBed┬« and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. GE Healthcare Giraffe Omnibed is a combination of an infant incubator and an infant warmer. HDGR52546, HDGR52736, HDGR52802, HDGR52861, HDGR52910, HDGR52958, HDGR53007, HDGR53058, HDGR53110, HDGR53185, HDGR52547, HDGR52737, HDGR52803, HDGR52862, HDGR52911, HDGR52959, HDGR53008, HDGR53059, HDGR53112, HDGR53186, HDGR52558, HDGR52739, HDGR52804, HDGR52863, HDGR52912, HDGR52960, HDGR53009, HDGR53060, HDGR53113, HDGR53187, HDGR52609, HDGR52740, HDGR52805, HDGR52864, HDGR52913, HDGR52961, HDGR53010, HDGR53061, HDGR53114, HDGR53188, HDGR52610, HDGR52741, HDGR52806, HDGR52865, HDGR52914, HDGR52962, HDGR53011, HDGR53062, HDGR53115, HDGR53189,  ...
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Class I Neonatal beds and incubator display boards may randomly overwrite stored information and radiant heater and oxygen set points upon power up or recovery from a power failure. GE Healthcare, LLC
Devices Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures. Part number 355.28, all lot numbers Class II Synthes is initiating a voluntary recall of the Flexible Grip (Part number 355.28) which is part of the Universal Nail System, due to the potential lack of the ability to thoroughly clean the instrument. Synthes USA HQ, Inc.
Food Canned Peach Slices in Light Syrup or canned Peach Slices in Heavy Syrup or canned Peach halves in Heavy Syrup. The PDP reads "HOOD-CREST ELBERTA PEACHES YELLOW FREESTONE SLICES IN LIGHT SYRUP NET WT. 28 OZ. (1LB. 12 OZ.) 793G" The back panel reads in part "***INGREDIENTS: PEACHES, WATER, SUGAR. MUIRHEAD CANNING CO. The Dalles, Ore. 97058***" The UPC on the label reads 7 88637 01111 7. The PDP reads "HOOD-CREST ELBERTA PEACHES YELLOW FREESTONE SLICES IN HEAVY SYRUP NET WT. 28 OZ. (1 LB. 12 OZ.) 793G" The back panel reads in part "***INGREDIENTS: PEACHES, WATER, SUGAR. Packed by MUIRHEAD CANNING CO. The Dalles, Ore. 97058. There is no UPC on the label. The PDP reads "HOOD-CREST ELBERTA PEACHES YELLOW FREESTONE HALVES IN HEAVY SYRUP NET WT. 28 OZ. (1LB. 12 OZ.) 793G" The back panel reads in part "*** INGREDIENTS: PEACHES, WATER, SUGAR MUIRHEAD CANNING CO. The Dalles, Ore. 97058***" There is no UPC on the label. Peach Slices in Light Syrup has a can code: fairtime 264 12:24. Peaches Slices in Heavy Syrup has a can code: elberta 265 12:24. These codes are interpreted as: Fairtime or Elberta peach type, Julian date 264 or 265, and processing time. The firm has not provided the code information for the peach  ...
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Class II potentially under processed and reports of swollen and bursting cans as well as discoloring fruit soon after opening the can and the fruit is undercooked (too firm), from consumers. Sage Creek Inc
Food Canned Pear Halves in Light Syrup or canned Pear Halves in Heavy Syrup. The PDP reads "HOOD-CREST HALVES BARTLETT PEARS IN HEAVY SYRUP NET WT. 28 OZ. (1 LB. 12 OZ.) 793G" and the back panel reads in part "***INGREDIENTS: PEARS WATER, SUGAR. Packed by MUIRHEAD CANNING CO. The Dalles, Ore. 97058***" There is no UPC on the label. For the light syrup the PDP reads "HOOD-CREST HALVES BARTLETT PEARS IN LIGHT SYRUP NET WT. 28 OZ. (1LB. 12 OZ.) 793G" The back panel reads in part "***INGREDIENTS: PEARS, WATER, SUGAR. MUIRHEAD CANNING CO. The Dalles, Ore. 97058***" The UPC on the label is 7 88637 01071 4. Pear Halves in Light Syrup has a can code: bartlett 285 12:24. This code is interpreted as: Bartlett type, Julian date 285, and processing time. The can code for Pears in Heavy Syrup is: BARTLETT 285 12:12 Class II Potentially under processed and reports of swollen and bursting cans as well as the fruit turning brown shortly after opening and the fruit is undercooked (firm) from consumers. Sage Creek Inc
Food Canned Apricot in Light Syrup or canned Apricot in Heavy Syrup. The PDP reads "HOOD-CREST APRICOTS UNPEELED HALVES IN LIGHT SYRUP NET WT. 28 OZ. (1LB. 12 OZ.) 793G". The back panel reads in part "*** INGREDIENTS: APRICOTS, WATER, SUGAR. MUIRHEAD CANNING CO. The Dalles, Ore. 97058***" The UPC is 7 88637 01031 8. The PDP reads "HOOD-CREST APRICOTS UNPEELED HALVES IN HEAVY SYRUP NET WT. 29 OZ. (1 LB. 13 OZ.) with the back panel reading in part "*** INGREDIENTS: APRICOTS, WATER, SUGAR Packed by MUIRHEAD CANNING CO. The Dalles, Ore. 97058***" There is no UPC on the label. Apricots in Heavy Syrup has a can code: paterson 195 12:24. This code is interpreted as: Paterson apricot type, Julian date 1955, and processing time. Apricots in Light Syrup's can code: PATERSON 195 12:12. Class II Potentially under processed and reports of swollen and bursting cans as well as fruit browning quickly after opening the can and undercooked (firm) fruit from consumers. Sage Creek Inc
Devices GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera. Nuclear Medicine imaging systems. Recall includes all Infinia systems, all configurations. 787764INFINIA-1 SA2146NM01 TN1366NM01 SA1001MN01 PK1031NM01 PK1032NM01 PK1180NM08 PK1184NM01 PK1307NM01 PK1336NM01 MA1439NM01 LB1122NM02 KW1013NM01 KW1013NM02 KW1018MN06 KW1018MN08 EG1124MN02 323268INF1 630312INF 630545INF 630856INF 630275INF 330344INFINIA1 518262INF1 518262INF2 518262INF3 724226INF1 ARHINFI 610770INFINIA 502893INF 443481BINF 443481INF 443481INF2 661949NUC1 804594INF1 480323INFRM1 607737INF 404265INF 330363INFINIA 920451INF 920907INF 305682INF1 602588INF 904821INF3 904821NM1 904821NM2 615284INF1 904627INF2 904321INF1 904202INF1  ...
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Class II Accelerated fatigue of the lateral axis motion subsystem of the Infinia Computed Emission Tomography System could result in mechanical failure causing the detector to slide; may impact patient and operators. GE Healthcare, LLC
Devices CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585, 3598, and 3599. Product Usage: Incubators are designed to maintain an optimal environment for the incubation of tissue and cell samples. These models are designed to maintain temperature, carbon dioxide, and humidity levels. 300028-325 to 30028-326; 300031-327 to 30031-331; 300111-332  ...
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Class II Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field. Thermo Fisher Scientific (Asheville) LLC
Devices Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Product Code: 030450 Applications in abdominal, gynecologic, pediatric anti thoracic surgery for resection, transection and creation of anastomosis. Lot Codes: N2F0563LX, N2F0341LX, N2F0725LX, and N2E0605LX. Class II Single Use Loading Unit contained two staples loaded in each cartridge pocket and may result in difficulty firing and removing the device from the application site, which may require medical intervention Covidien LP
Devices The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part's numbers: 3200731-xxx, 3202177-xxx, U3200731-xxx, and U3202177-006. Automated external defibrillators. 33219251, 33220310, 33220344, 33220367, 33220369, 33220376, 33220402, 33220450, 33220461, 33220464, 33220466, 33220470, 33221200, 33221394, 33231481, 33231486, 33231488, 33231492, 33231511, 33231512, 33231521, 33231523, 33231524, 33231527, 33231532, 33231535, 33231536, 33231539, 33231545, 33231546, 33231554, 33231611, 33231614, 33231618, 33231623, 33231625, 33231628, 33231635, 33231636, 33231639, 33231641, 33231685, 33231712, 33231728, 33231733, 33231737, 33231741, 33231745, 33231755, 33231758,  ...
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Class II LIFEPAK CR Plus or LIFEPAK Express Automated External Defibrillators (AEDs) are recalled due to the potential to experience an early internal battery depletion issue. Physio Control, Inc.
Food GREEN DAY brand White Melon Seeds, Net Wt. 9.8 oz (280g) , UPC 6 868978 724120, Produce of P.R.C. --- Firms on Label: Manufacturer: Jiangmen Xinhui Parksun Food Co., Ltd. Add: Donggua Hill, Beltou Village, Qibao, Xinhui District, Jiangmen City, Guangdong -- Packed For: Domega NY International Co., ltd. 1915 West 13th Street Brooklyn, N.Y. 11223 --- Nutrition Facts: Serving Size (illegible) Servings Per Container 4 --- The product is packaged in a clear, plastic bag on a plastic tray insert. MFD 09/30/2013 EXP 09/29/2014 Class I The product contained undeclared sulfites (1539 ppm) based on sampling & analysis by New York State Department of Agriculture & Markets. Domega NY International Co Ltd
Drugs Cefdinir for Oral Suspension, 125 mg/5 mL, packaged in a) 60 mL bottle (NDC 0093-4136-64); b) 100 mL bottle (NDC 0093-4136-73), Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960. a) Lot #: 30304253A, Exp 12/13; b) Lot #: 30304144A, Exp 12/13 and 30304477A, Exp 03/14 Class II Defective Container: This recall is being carried out due to the potential for improperly sealed bottles. Teva Pharmaceuticals USA, Inc.
Devices Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. Intended for use in reconstruction of the articulating surface of the acetabular portion of the hip. Part Numbers SC3458-52, lot number 28820-112612; SC3474-52, lot number 28822-101812; SC3459-52, lot number 28823-101812; and SC3460-52, lot number 28821-000. Class II Firm was made aware of incidents relating to the difficulty of properly engaging and securing the Cross-Over 36mm liner into the Cross-Over shell. Stelkast Co
Biologics Pine, Australian Allergenic Extract P46050812A Class III Allergenic Extracts, reprocessed by an unapproved process, were distributed. Antigen Laboratories Inc
Devices Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy. Lot Numbers: KF2073734 KS2083999 KF2083869 KF2083921 Class II Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter. Arrow International Inc
Devices Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Number: IAB-05840-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy. Lot Numbers: KF2073694 KF2083874 KF2083966 KF2094179 KF2073788 KF2083927 KF2084059 Class II Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter. Arrow International Inc
Devices Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0. Used for cementation of all indirect restorations. 34417 KIT- MAXCEM ELITE INTRO 2-4662052 4672087 4694484 4698107 4710901 4719936 4725775 4725776 34418 KIT - MAXCEM ELITE BULK-4706738 4656479 4656480 4666810 4666811 4666813 4668612 4709788 4710900 4712887 4725780 4729919 4734053 4744195 SYRINGE LOT NUMBERS 34417 & 34418 SYRINGE- MAXCEM ELITE CLEAR Individually affected syringes within Kits listed above-4663716 4663717 4690551 4690552 4704821 4728088 4741721 33872 REFILL- MAXCEM ELITE CLEAR-4664825 4669840 4669841 4672089 4676812 4676815 4678974 4678975 4690548 4690549 4690550 4702597 4710904 4710905 4718097 4720553 4720555 4720558 4720560 4720562 4720563 4720564 4720565 33873 REFILL- MAXCEM ELITE WHITE-4681749 4699954 4704804 4720556 4720567 4720568 4720569 4720573 4720574 4720575 33874 -REFILL- MAXCEM ELITE WHITE OPAQUE-4720576 4720577 4720578 4720579 4720580 33875-REFILL- MAXCEM ELITE YELLOW -4652147 4696832 4720198 33876 -REFILL- MAXCEM ELITE BROWN -4710907 4725879 34055 MAXCEM ELITE STANDARD  ...
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Class II Kerr Corporation is initiating this recall because raw material used to produce the Maxcem Elite is causing the material to prematurely polymerize in the syringe. The product could be difficult to extrude or demonstrate a shorter work-time as the material may prematurely set prior to placing restorations on the tooth or core build-up. As a result, the restoration may not be seated properly. Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Biologics Blood bank software Primary Application with Model numbers 5.4.0; 5.4.0.1; 5.4.0.2; and 5.4.1 Model numbers 5.4.0; 5.4.0.1; 5.4.0.2; and 5.4.1 Serial numbers: 0001846, 0001847, 0001848, 0001849, 0001850, 0001851, 0001852, 0001853, 0001854, 0001855, 0001856, 0001857, 0001858, 0001859, 0001860, 0001861, 0001862, 0001863, 0001864, 0001865, 0001866, 0001867, 0001868, 0001869, 0001870, 0001871, 0001872, 0001873, 0001874, 0001875, 0001876, 0001891, 0001892, 0001893, 0001894, 0001895, 0001896, 0001897, 0001898, 0001899, 0001900, 0001901, 0001902,  ...
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Class II Blood Bank Software, with a defect or glitch, was distributed. Blood Bank Computer Systems, Inc
Biologics Blood bank software Primary Application with Model numbers 5.4.0; 5.4.0.1; 5.4.0.2; and 5.4.1 Model Numbers 5.4.0; 5.4.0.1; 5.4.0.2; and 5.4.1 Serial numbers: 0001846, 0001847, 0001848, 0001849, 0001850, 0001851, 0001852, 0001853, 0001854, 0001855, 0001856, 0001857, 0001858, 0001859, 0001860, 0001861, 0001862, 0001863, 0001864, 0001865, 0001866, 0001867, 0001868, 0001869, 0001870, 0001871, 0001872, 0001873, 0001874, 0001875, 0001876, 0001891, 0001892, 0001893, 0001894, 0001895, 0001896, 0001897, 0001898, 0001899, 0001900, 0001901, 0001902,  ...
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Class II Blood Bank Software, with a defect or glitch, was distributed. Blood Bank Computer Systems, Inc
Biologics Blood bank software Primary Application 5.4.0.1; 5.4.0.2; and 5.4.1 Model numbers: 5.4.0.1; 5.4.0.2; and 5.4.1 Serial numbers: 0001891, 0001892, 0001893, 0001894, 0001895, 0001896, 0001897, 0001898, 0001899, 0001900, 0001901, 0001902, 0001903, 0001904, 0001905, 0001906, 0001907, 0001908, 0001909, 0001910, 0001911, 0001912, 0001913, 0001914, 0001915, 0001916, 0001917, 0001918, 0001919, 0001920, 0001921, 0002018, 0002029, 0002030, 0002031, 0002032, 0002033, 0002034, 0002035, 0002036, 0002037, 0002038, 0002039, 0002040,  ...
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Class II Blood Bank Software with a defect or glitch, was distributed. Blood Bank Computer Systems, Inc
Biologics Blood bank software Primary Application 5.4.0.2 and 5.4.1 Model numbers: 5.4.02 and 5.4.1 Serial numbers: 0002029, 0002030, 0002031, 0002032, 0002033, 0002034, 0002035, 0002036, 0002037, 0002038, 0002039, 0002040, 0002041, 0002042, 0002043, 0002044, 0002045, 0002046, 0002047, 0002048, 0002049, 0002050, 0002051, 0002052, 0002053, 0002054, 0002055, 0002056, 0002057, 0002058, 0002059, 0002060, 0002061, 0002062, 0002063, 0002064, 0002065, 0002066, 0002067, 0002068, 0002069, 0002070, 0002071, 0002072, 0002073,  ...
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Class II Blood Bank Software, with a defect or glitch, was distributed. Blood Bank Computer Systems, Inc
Food Nutrex Research Lipo 6 Black Ultra concentrate Fat Destroyer Lot # 50000114 Best by: 01/2015 Class I Product samples contain DMAA (Methylhexanamine). Nutrex Research, Inc.
Drugs Portia (levonorgestrel and ethinyl estradiol) Tablets, USP, 0.15 mg/0.03 mg, 28-count tablets (containing 21 pink tablets followed by 7 white tablets) per blister card packaged in 6 blister cards per carton, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-9020-58. Lot #: 33801951A, and 33802189A, Exp 03/13 Class III Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance. Teva Pharmaceuticals USA, Inc.
Drugs Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 91-count tablets per extended-cycle tablet dispenser packaged in 3 dispensers per carton, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-9123-66. Lot #: 33803603A, 33803604A, Exp 11/13; 33803996A, and 33803997A, Exp 03/14 Class III Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance. Teva Pharmaceuticals USA, Inc.
Food NewChapter Probiotic Elderberry, 90 vegetarian capsules bottle. Dietary Supplement UPC: 7-27783-00123-8 Lot: 01230049332 Expiration date: 01/31/15 (located on the bottom of the box and on the side of the bottle) Class I The product may contain an undeclared allergen soy New Chapter, Inc.
Food Proti Diet High Protein Chocolate Dream Bar, is sold in 210 g packages (7 bars per package) UPC 6 21498 42238 1 Lot code CR 18 13B, and Best Before: 2015-08. Class I Product may be contaminated with Salmonella Nashua Nutrition
Biologics Plasma Frozen within 24 hours (FP24) after phlebotomy, 281 ml from CP20 Whole Blood, Store at -18 degrees Celsius or colder. W044212478995 W044212486280 W044212491475 W044212490604 W044212489880 W044212489075 W044212482806 W044212489045 W044212492913 W044212486252 W044212482004 W044212489030 W044212492982 W044212492969 W044212485939 W044212485901 W044212492910 W044212492946 W044212490488 W044212484516 W044212486182 W044212481886 W044212486246 W044212489023 W044212492916 W044212489032 W044212492936 W044212478942 W044212478945 W044212490216 W044212490220 W044212486210 W044212481332 W044212489122 W044212481498 W044212481501 W044212491923 W044212486752 W044212485714 W044212490527 W044212490480 W044212490167 W044212490176 W044212489019 W044212489131 W044212482555 W044212482547 W044212490285 W044212490320 W044212490524  ...
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Class III Unlicenseed blood products were distributed in interstate commerce. San Diego Blood Bank
Food Mikesell's Honey Barbecue TOMATO AND SPICES WITH A HINT OF SWEET FLAVORED POTATO CHIPS Gluten Free 1 oz., 2 oz., 6 oz., 10 oz., 16 oz. MIKESELL'S SNACK FOOD CO. P.O. BOX 115 DAYTON, OH 45404. All lots with with Sell By Dates on or before May 21 1 oz. UPC code: 0-71104-10171-9 2 oz. UPC code: 0-71104-40170-3 6 oz. UPC code: 0-71104-60152-3 10 oz. UPC code: 0-71104-50176-2 16 oz. UPC code: 0-71104-10154-5 Class II The firm received complaints of illness involving the product. Further investigation revealed that the package was mislabeled as "Gluten Free" Mike-Sells Potato Chip Co
Devices IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management. Softwaer version: IMPAX CR 7.8 SU3 Optical Character Recognition (OCR) Service Class II Software design error in IMPAX CV 7.8 SU3 AGFA Corp.
Devices Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA A subsidiary of Stryker Corporation. Made in USA. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France The Baseplate Impactor Extractor is intended to securely attach to the tibial baseplate or baseplate trial for impaction and extraction during surgery. Catalog Number 6541-4-805. Lot Numbers: RD4V204; RD5V234; RD5V235; RD5V235A; RD5V235Y; RD5V236; RD5V236A; RD5V237; RD6A009; RD6A010; RD6A011; RD6A011P; RD6A012; RD6A051; RD6A052; RD6A053; RD6A053M; RD6A053T; RD6A061; RD6A061A; RD6A062; RD6A062N; RD6A063; RD6A063T; RD6A065; RD6A065D; RD6A065T; RD6A066; RD6A066A; RD6C103; RD6C103L; RD6C104; RD6C104Y; RD6C105; RD6C105M; RD6C105T; RD6C106; RD6C106A; RD6C108; RD6C109; RD6C109L; RD6C126; RD6H178; RD6H184; RD6H187;  ...
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Class II Stryker received reports from the field indicating that the handle detached from the cam of the Baseplate Impactor/Extractor Assembly. Stryker Howmedica Osteonics Corp.
Devices IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease. Model # L9M21000. Software versions: IMPAX CV 7.8, 7.8 SU1, 7.8 SU2 and 7.8 SU3, IMPAX CV 7.8 SU2.5 with IMPAX CV Outbound Report Stylesheet 7.8_HL Class II Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the hospital's electronic health record (EHR) system. AGFA Corp.
Biologics Heart Valve 10045270 Class III Human tissue allograft, recovered from a donor whose donor eligibility determination did not confirm the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseeases, was distributed. CryoLife, Inc.
Devices Precise Treatment Table. To be used as part of radiation therapy treatment process. 151855, 151611, 152008, 151587. 151694, 152019, 105864, 105932, 151574, 151267, 152397, 152248, 152559, 151875, 151965, 151369, 152502, 105829, 152262, 151504, 151159, 105941, 151418, 151538, 105990, 151674, 105555, 151729, 151399, 105809, 151802, 151421, 152427, 129032, 105803, 152652. 152659, 152715, 152117, 152803, 151566, 152271, 151736, 151700, 105895, 151866, 151259, 151698, 151699, 151636,  ...
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Class II The Column rotation can accidentally be moved to a different position which in the locked position. Elekta, Inc.
Devices T SX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce cross-sectional images of a human body. Serial Numbers: HDA0722595 JDA0972130 JDA0972135 JDA0992147 JDA09Y2158 KDA09X2063 JDA09Y2157 JDA09Y2161 JDA1012171 JDA10X2191 JDA10X2197 JDA10Z2214 JGAl112220 JLA1122232 JLA1132235 JDAl112216 JDAl112219 NLA0972032 JDA1182242 JDA1182241 JDA1182244 JDA1072183 JDA1082189 Class II It was found that in vHP scan, the estimated DLP (total exposure dose of all scans in a single examination) value displayed in the eXam Plan window in scan planning and the DLP value displayed in the summary after scanning are incorrect. Toshiba American Medical Systems Inc
Devices MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System. The majority ofthe letters are sent via USPS return  ...
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Class II It was found that there is a problem with the LCD monitor used in the console. The LCD monitor may become blank during use. Specifically, the backlight of the LCD monitor may turn off while the system is in use, causing the LCD monitor to become blank. However, the other parts of the system continue to operate normally, and the risk of a serious health hazard is therefore very low. The LCD Monitor will be replaced with a new monitor. Toshiba American Medical Systems Inc
Food Ferrous Sulfate Tablets 325 mg, 100 count bottles, Nutritional Supplement. Label reads in part "OPTIMUM *** FERROUS SULFATE 325 * mg 5 Grain *** Gluten Free Dietary Supplement *** Manufactured & Distributed by: Magno-Humphries Labs Tigard, OR 97223 U.S.A. *** *325 mg calculated as Ferrous Sulfate Heptahydrate. ***" UPC 0 43292 56306 0 There are 72 bottles per shipping case and most product is shipped by case. Product code -L6430-100-01(L is designate label, 6430 is the firm's internal product code, 100 is for 100 count and 01 stands for Optimum label, and 0 is the firm's version number. All of these products have the same label code, however; they have different lot numbers. Lot Numbers: 343617, 343718, 343739,  ...
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Class III The firm found minute pieces of blue material identified by their raw material supplier as polypropylene, a relatively inert plastic. Magno Humphries Inc
Devices Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning. Serial No: 1CB1262006 Class II It has been found that due to a problem with the control software of the x-ray high-voltage generator, if scanning is performed with a tube current less than 30mA, the control software may detect an error and perform error processing even though the x-ray output is normal. Toshiba American Medical Systems Inc
Devices Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. Angiographic x-ray system. Model Number 5902767 with serial numbers 2217, 2038, 1228, 1007, 1219, 2156, 2264, 2190, 2132, 2213, 1484, 2166, 2259, 2068, 1610, 1601, 1413, 2236, 2153, 1444, 1477, 1632, 2037, 2180, 1663, and 1612; Model Number 5902783 with serial numbers 1003, 1401, 1402, and 1405; Model Number 7152478 with serial numbers  ...
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Class II Siemens has become aware of a potential malfunction and possible hazard to patients and staff when using the Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. This malfunction is possible in cases where the table vertical lift movement is obstructed by a solid object which could potentially result in collision. This can result in damage to system mechanics that may not necessarily prevent the table from functioning immediately, but can lead to complete failure of the table mounting mechanics. It is possible that the table may drop, resulting in potentially hazardous situations for patients and/or staff. Siemens Medical Solutions USA, Inc
Food Sunchang Ssamjang Sesame and Garlic Seasoned Bean Paste 500 g - Net Wt. 17.64 oz., UPC Code 880152435671 Distributed by: Daesang America, Inc. Hackensack, NJ 07601 TEL: (201) 488-4010 Product of Korea All expiration dates. Recalled product was distributed from June 2012 to Feb. 2013. Class I Sesame and Garlic Flavored Mixed Soy Bean Paste contains peanut powder which is included in the Korean ingredient listing but not the English ingredient listing. Daesang America Inc
Drugs LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP, 20 mg/25 mg, 100 (NDC 60429-046-01) and 1,000 (NDC 60429-046-10) count bottles, Rx only, GSMS Inc., Camarillo, CA Exp NDC Lot # Date 60429-046-10 69393A1 09/2015 60429-046-1 0 69395A1 09/2015 60429-046-10 69495A1 10/2015 60429-046-10 69496A1 10/2015 60429-046-01 69497A1 02/2014 60429-046-10 69524A1 10/2015 60429-046-10 69524A2 10/2015 60429-046-10 69525A1 10/2015 60429-046-10 69525A2 10/2015 Class II Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets by the manufacturer Gsms
Food MUSCLEPHARM brand COMBAT POWDER (R), COOKIES 'N' CREAM, NATURAL AND ARTIFICAL FLAVORS, HYBRID SERIES DIETARY SUPPLEMENT, NET WEIGHT 2 LBS (907 GRAMS), EXCLUSIVELY DEVELOPED AND MANUFACTURED FOR: MUSCLEPHARM(TM) CORP., 4721 Ironton St., Denver, CO, 80239, UPC 736211050670 Lot # 123932 026, Expiration date 02/2015 Class II One lot of each product may have extraneous materials due to a problem on the packing line. F.H.G Corporation dba Integrity Nutraceuticals
Food MUSCLEPHARM brand COMBAT POWDER (R), BANANA CREAM, NATURAL AND ARTIFICAL FLAVORS, HYBRID SERIES DIETARY SUPPLEMENT, NET WEIGHT 2 LBS (907 GRAMS), EXCLUSIVELY DEVELOPED AND MANUFACTURED FOR: MUSCLEPHARM(TM) CORP., 4721 Ironton St., Denver, CO, 80239, UPC 736211050571 Lot # 123732 027, Expiration date 02/2015 Class II One lot of each product may have extraneous materials due to a problem on the packing line. F.H.G Corporation dba Integrity Nutraceuticals
Devices GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revisions R1.0.1, R1.0.2 and R1.0.3) diagnostic ultrasound system with the S4-10-D Ultrasound Probe. The device is intended for use in ultrasound evaluation. 176132SU9 176138SU6 178028SU7 158247SU7 172656SU1 187599SU6 201614SU5 201615SU2 195234SU0 195237SU3 161686SU1 203123SU5 170272SU9 189160SU5 189162SU1 170273SU7 185619SU4 176924SU9 191894SU5 159964SU6 159768SU1 170197SU8 158248SU5 171540SU8 171541SU6 160741SU5 160742SU3 160743SU1 159766SU5 197761SU0 198949SU0 195241SU5 189928SU5 164268SU5 159963SU8 185116SU1 195242SU3 201967SU7 166218SU8 185968SU5 189165SU4 189166SU2 189167SU0 189168SU8 189169SU6 195235SU7 195236SU5 171371SU8 168779SU7 189163SU9  ...
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Class II GE Healthcare has become aware of a potential safety issue due to the S4-10-D Ultrasound Probe used in conjunction with the LOGIQ S8 and LOGIQ S7 Ultrasound systems. It was also discovered that this issue also leads to a specification issue of the acoustic output of this probe. There is a potential for a skin burn when the flow model in the cardiac application is activated with the S4-10-D Ultrasound probe. GE Healthcare, LLC
Devices Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodontic wires used to move teeth during orthodontic treatment Part Number 438-0184 Lot Number 051063597 Class II Ormco Corporation is voluntarily recalling one (1) lot of Bracket Buccal Tubes as a result of a packaging error. More specifically, the Bracket Buccal Tubes product package correctly identifies the product as gingival (0┬░) offset brackets, but actually contains distal (10┬░) offset brackets. Use of the affected product may cause unintended rotation of the molars. Although reversible, a delay in treatment could occur. Ormco/Sybronendo
Food NatureBox brand Umami Almonds packed in branded stand-up pouches (whole tamari flavored almonds), Net wt. 4.3 oz. No UPC Codes on the product, Product is processed and packaged by NatureBox, San Carlos, CA; NOTE: Product label DOES declare that it is "Packed in a facility that also processes tree nuts, peanuts, milk, wheat, and soy" below the ingredient statement. All lot codes with Best By Dates or 5/15/13 or earlier. Class II Product may contain wheat allergen. Wheat is not listed in the ingredient statement. NatureBox, Inc.
Devices Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. . REF 8-205508-00 Lot Number: 820550800110419. Class I The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates. Engineered Medical Systems,Inc
Devices Medtronic MiniMed Paradigm Insulin Infusion Pumps Model Numbers: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. Product Usage: Paradigm insulin infusion pumps are intended for use to deliver basal and bolus insulin to persons with diabetes. Not available Class II Medtronic is recalling the Medtronic Paradigm Insulin Pump because the pump's drive support cap may become detached from the pump case and protrude from the lower right side of the pump. When the pump is expose to water it may result in damage to the pump's internal electronics. This moisture damage can prevent the pump's buttons from working properly or can cause the pump to alarm. Medtronic MiniMed
Food Product does not have a label. The consignees are provided with an ingredient statement for all the products they purchase. The product is packaged in a reusable plastic tote, with white sticker applied to one side of tote. This sticker has the Prepared Date: which is hand written as the month-day. 3/19/2013 through 3/27/2013 Class II There is the possibility of what appears to be plastic/paint shavings in the container holding the raw cookie product. New Seasons Market
Devices VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139; 45296200; 45296350; 45296477; 45296964; 45297001; 45296966; 45297003; 2240169; 2240171; 2240172; 2240173. Product Usage: The VMX is a mobile radiography system incorporating stylish design for totally adapted use in intensive care, emergencies, pediatrics, neonatology and orthopedics. 00000155075MO5 00000006136YY6 00000006802YY3 00000006799YY1 00000007989YY7 00000007990YY5 00000002358YY0 00000021131YY8 00000021132YY6 00000021146YY6 00000021139YY1 00000021141YY7 00000021159YY9 00000041750YY1 00000021108YY6 00000041725YY3 00000041778YY2 00000083296YY4 00000085032YY1 00000118252MO6 00000085956YY1 00000160478MO4 00000021116YY9 00000021017YY9 00000011088YY2 00000024550YY6 00000021097YY1 00000031512YY7 00000031585YY3 00000025793YY1 00000002355YY6 00000006148YY1 00000147625MO8 00000021024YY5 00000021134YY2 00000021140YY9 00000024543YY1 00000021103YY7 00000021107YY8 00000021151YY6 00000041762YY6 00000041772YY5 00000041768YY3 00000041766YY7 00000041764YY2 00000041771YY7 00000041770YY9 00000041784YY0 00000041783YY2 00000083295YY6  ...
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Class II GE Healthcare has become aware of an issue associated with the base casting for the articulated arm of your VMX and VMX Plus Mobile X-ray systems that may impact Operator or Patient safety. GE Healthcare, LLC
Devices GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Product Usage: It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra,dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate,blood vessels, and musculoskeletal regions of the body. Serial Number 00000000UA0027 00000000UA0012 00000000UA0029 00000000UA0031 00000000UA0030 00000000UA0028 00000000UA0034 00000000UA0038 00000000UA0048 00000000UA0046 00000000UA0052 00000000UA0041 00000000UA0011A 00000000UA0055 00000000UA0056 00000000UA0057 00000000UA0064 00000000UA0053 00000000UA0044 00000000UA0047 00000000UA0010 00000000UA0013 00000000UA0017 00000000UA0042 00000000UA0016 00000000UA0019 00000000UA0015 00000000UA0058 00000000UA0051 00000000UA0025 00000000UA0024 00000000UA0020 00000000UA0040 00000000UA0018 00000000UA0036 00000000UA0043 00000000UA0054 00000000UA0022 00000000UA0023 00000000UA0045 00000000UA0039 00000000UA0035 00000000UA0049 00000000UA0021 00000000UA0033 00000000UA0037 Class II GE Healthcare has recently become aware of a potential issue due to image flip in frequency encoding direction associated with a specific workflow of your Discovery MR750w system. Image flip issue in frequency encoding direction (including S/I, A/P and R/L) can result in incorrect localization of anatomy and pathological findings. GE Healthcare, LLC
Devices LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povidone Iodine, antiseptic towelette. Kit Number: 2113110. First Aid Kit. All kits shipped between 1/12010 through 3/4/2013. Class III The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterilized. Some product labeling states "Sterility guaranteed unless seal broken" or "Contents sterile if package is intact." These claims were intended to indicate surface sterilization only but could mistakenly lead to the conclusion that the drug product solution is sterile. It was determined that labeling on certain products could be misleading in relation to sterility claims. Lighthouse For The Blind
Devices LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Number: 2113305. First Aid Kit. All kits shipped between 1/12010 through 3/4/2013. Class III The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterilized. Some product labeling states "Sterility guaranteed unless seal broken" or "Contents sterile if package is intact." These claims were intended to indicate surface sterilization only but could mistakenly lead to the conclusion that the drug product solution is sterile. It was determined that labeling on certain products could be misleading in relation to sterility claims. Lighthouse For The Blind
Devices LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit number: 2114002. First Aid Kit. All kits shipped between 1/12010 through 3/4/2013. Class III The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterilized. Some product labeling states "Sterility guaranteed unless seal broken" or "Contents sterile if package is intact." These claims were intended to indicate surface sterilization only but could mistakenly lead to the conclusion that the drug product solution is sterile. It was determined that labeling on certain products could be misleading in relation to sterility claims. Lighthouse For The Blind
Devices LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid Kit. All kits shipped between 1/12010 through 3/4/2013. Class III The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterilized. Some product labeling states "Sterility guaranteed unless seal broken" or "Contents sterile if package is intact." These claims were intended to indicate surface sterilization only but could mistakenly lead to the conclusion that the drug product solution is sterile. It was determined that labeling on certain products could be misleading in relation to sterility claims. Lighthouse For The Blind
Devices LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011. First Aid Kit. All kits shipped between 1/12010 through 3/4/2013. Class III The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterilized. Some product labeling states "Sterility guaranteed unless seal broken" or "Contents sterile if package is intact." These claims were intended to indicate surface sterilization only but could mistakenly lead to the conclusion that the drug product solution is sterile. It was determined that labeling on certain products could be misleading in relation to sterility claims. Lighthouse For The Blind
Devices LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit. All kits shipped between 1/12010 through 3/4/2013. Class III The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterilized. Some product labeling states "Sterility guaranteed unless seal broken" or "Contents sterile if package is intact." These claims were intended to indicate surface sterilization only but could mistakenly lead to the conclusion that the drug product solution is sterile. It was determined that labeling on certain products could be misleading in relation to sterility claims. Lighthouse For The Blind
Devices LHB, First Aid Type IV Belt Type, NSN #6545-01-010-7754. Kit number: 114016. First Aid Kit. All kits shipped between 1/12010 through 3/4/2013. Class III The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterilized. Some product labeling states "Sterility guaranteed unless seal broken" or "Contents sterile if package is intact." These claims were intended to indicate surface sterilization only but could mistakenly lead to the conclusion that the drug product solution is sterile. It was determined that labeling on certain products could be misleading in relation to sterility claims. Lighthouse For The Blind
Devices LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit. All kits shipped between 1/12010 through 3/4/2013. Class III The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterilized. Some product labeling states "Sterility guaranteed unless seal broken" or "Contents sterile if package is intact." These claims were intended to indicate surface sterilization only but could mistakenly lead to the conclusion that the drug product solution is sterile. It was determined that labeling on certain products could be misleading in relation to sterility claims. Lighthouse For The Blind
Food ShanTea Enlightened Mind Mate/Kukicha (UPC 794504284102) USDA Organic. Lot 1354 Class II This recall has been initiated due to the potential for the possibility of Salmonella contamination. ShanTea LLC
Food ShanTea Ride The Dragon Honeybush/Licorice (UPC 794504283808) USDA Organic. Lot 1354 Class II This recall has been initiated due to the potential for the possibility of Salmonella contamination. ShanTea LLC
Food Large Cheese Crisp & Burrito Size, one dozen, net wt. 30 oz No Lot codes, UPC 46847 77782 Class II Red Eagle Enterprises is recalling Red Eagle Brand Flour tortilla products because they contain undeclared wheat. Red Eagle Enterprises
Food Lite Thin Tortillas, one dozen., net wt. 15 oz No Lot codes, UPC 46847 77780 Class II Red Eagle Enterprises is recalling Red Eagle Brand Flour tortilla products because they contain undeclared wheat. Red Eagle Enterprises
Food Small Flour Gorditas, one dozen, net wt. 24 oz No Lot codes, UPC 46847 77781 Class II Red Eagle Enterprises is recalling Red Eagle Brand Flour tortilla products because they contain undeclared wheat. Red Eagle Enterprises
Devices Torrent" irrigation tubing. Product Usage: The Torrent irrigation system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit. Product code: 00711560; Lot #'s: 79687, 79688, 79689, 79690, 79691, 79692, 79693, 79694, 79695, 79696 80165, 80166, 80709, 80710, 80711, 80712, 80713, 80714, 80715, 80716, 80717, 80718, 80719. 80720, 80721, 80722, 80723, 81245, 81246, 81247, 81248, 81249, 81250, 81251, 81252, 81253, 81254, 81255, 81256, 81257, 81258, 81259, 81982, 81983, 81984,  ...
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Class II The firm was notified by their customers that there was a water leakage from the white tubing connector. US Endoscopy Group Inc
Devices Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200; The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. All units of this model. Class II When using the V5M transducer, the display of the temperature on the ACUSON SC2000 system can be lower than the actual temperature of the V5M transducer. This occurs only if the system hardware contains revision 4 of the MPI Board. There is a potential to cause esophageal burns in patients. Siemens Medical Solutions USA, Inc.
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