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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Drugs Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle (NDC 60505-2502-3), Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9 Lot #: a) GY4197, Exp 11/07; b) GZ1273, Exp 11/07. Class II Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications. Apotex Corp.
Drugs Leflunomide tablets, 20 mg, 1000-count bottle, Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9, NDC 60505-2503-3 Lot #: GZ1274, Exp 11/07. Class II Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications. Apotex Corp.
Biologics Red Blood Cells Leukocytes Reduced 6553449 Class II Blood products, which were collected from a donor with a history of high risk behaviors, were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Blood and Blood Products for Reprocessing 6553449 Class II Blood products, which were collected from a donor with a history of high risk behaviors, were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 3739350 (Part A), 3739350 (Part B) Class II Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Red Blood Cells Leukocytes Reduced W045007065480 Class III Blood product, collected from a donor for whom the arm appearance was not acceptable was distributed. Community Blood Center Of Gtr KC
Biologics Red Blood Cells Leukocytes Reduced Irradiated 02LH70356 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. American Red Cross Blood Services
Biologics Source Plasma 0340752007;0340751638;0340751124;0340750763;0340750089;0340749799;0340749296;0340748991;0340748506;0340748231;0340747468;0340746923;0340746544;0340746190;0340745429;0340745059;0340744705;0340744184;0340743964;0340742694;0340742245;0340741881;0340741554;0340741120;0340740607;0340740379;0340739736;0340739433;0340739020;0340738623;0340737941;0340737774;0340737379;0340737063;0340735931;0340735369;0340735184 Class II Blood products, collected from a donor who was permanently deferred, were distributed. ZLB Bioplasma, Inc.
Biologics Red Blood Cells Leukocytes Reduced W045005046954 Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Community Blood Center of Greater Kansas City
Biologics Red Blood Cells W045005031764; W045005093155 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Community Blood Center of Greater Kansas City
Biologics Red Blood Cells Leukocytes Reduced W045006012221 Class II Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed. Community Blood Center Of Gtr KC
Biologics Blood and Blood Products for Reprocessing W045006012221 Class III Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed. Community Blood Center Of Gtr KC
Biologics Red Blood Cells Leukocytes Reduced 6041690 Class II Blood products, collected from a donor taking the medication Propecia, were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Blood and Blood Products for Reprocessing 6041690 Class II Blood products, collected from a donor taking the medication Propecia, were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Red Blood Cells Leukocytes Reduced 6066046; 6070284; 6073935; 6075510 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Blood and Blood Products for Reprocessing 6067919; 6070284; 6075510 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Platelets Pheresis Leukocytes Reduced KN07114 Class II Blood product, collected using apheresis kits with small detected leaks, was distributed. Mississippi Valley Regional Blood Center
Biologics Blood and Blood Products for Reprocessing 6526423 Class II Blood products, collected from a donor with a history of Hepatitis A, were distributed Community Blood Bank of Lancaster County Medical Society
Biologics Red Blood Cells Leukocytes Reduced 6526423; 6510805 Class II Blood products, collected from a donor with a history of Hepatitis A, were distributed Community Blood Bank of Lancaster County Medical Society
Biologics Red Blood Cells Leukocytes Reduced W045007093412 Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Community Blood Center of Greater Kansas City
Devices Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also commonly known as convenience kits and custom procedure trays) are an assembly of medical devices packaged together according to the customer specifications, which are then wrapped in a sterilization wrap and sterilized. This allows the customer to open one package for a surgical procedure instead of many individual packages. Model Numbers: CY1020 GY1250 GY1274 GY1274A GY1274B GY1274C GS1296 NU1290 OR1288 OR1288A OR1289 GS0880C GS0880D GS0880E GS0880F LD0994D LD1000A GS0983C LD1019A LD1019B LD1029A OR0986B OR0986C OR0986D GS0935B-M GY1223 GY1223A CY1028C CY1028D ET1023A ET1023B ET1023C ET1023D EY1024A EY1024B EY1024C EY1024D EY1024E GS0764D GS0764E GS0780D GS0780E GS1219 LD1022B LD1022C LD1022D LD1132 LD1132A  ...
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Class II Distribution of a product that did not meet specifications. (labeling error) SRI Surgical
Biologics Red Blood Cells Leukocytes Reduced 6073807; 6070221; 6067675 Class II Blood products, which were collected from a donor who had lived in a malarial endemic area, were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Platelets Pheresis Leukocytes Reduced W038308081577;W038308071828;W038308052365 Class III Blood products, which were labeled with an incorrect volume, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Source Plasma/Liquid Plasma 4240228453;4240222051;4240221194;4240220429 4240217429;4240217015;4240215818;4240215153 4240214180;4240213527;4240212618;4240211936; 4240211053;4240210380;4240204976;4240203217; 4240202258;4240201459;4240200737;4240199762 4240198982;4240198238;4240197408;4240196568; 4240195885 4240194962;4240194221;4240193356; 4240192718;4240191996;4240191136;4240190596; 4240189368;4240189069;4240188121;4240187675; 4240186875;4240186466;4240185529;4240185085 4240184047;4240183522;4240182433;4240181871; 4240180806;4240180300;4240166955;4240166504; 4240165368;4240164901;4240163784;4240162932; 4240162091;4240161313;4240160497;4240158208; 4240157190;4240155530;4240155054;4240152977 4240152542;4240151504;4240150999;4240150060; 4240149516;4240148483 Class II Blood products, collected from a donor whose physical was rescheduled as a sample only, were distributed. Csl Plasma Inc
Biologics Source Plasma 4150162098;4150159365;4150158968;4150157895 4150157508;4150154891;4150153300;4150150738 4150149785;4150149203;4150147948;4150147223; 4150146605;4150145206;4150142055;4150141380 4150139234;4150138581;4150135674;4150135265 4150131794;4150131382;4150126722;4150126413 4150124573;4150124379;4150122978;4150122592; 4150120868;4150120657;4150119094;4150118448 4150117306;4150117012;4150112756;4150112283 4150109774 Class II Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Csl Plasma Inc
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W087908303776(Part A); W087908303776(Part B) Class II Blood products, which did not meet the acceptable product specifications for release, were distributed. Community Blood Bank of Lancaster County Medical Society
Devices TRESTLE LUXE® Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bone screws to provide the versatility required for the specific indications noted. Fixation is achieved by means of a rigid plate that is surgically attached to the spine with bone screws. The TRESTLE LUXE Anterior Cervical Plating System is intended for use in the anterior cervical spine (C2-C7). Patients with trauma (including fractures), spondylolisthesis, and pseudoarthrosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, tumors, and failed previous fusion. Product code KWQ. 510(k) K102820 Part Number 71721. Lot numbers: 6629701, 6594701, 6434301, 6434302, 6434302R1. Class II On May 9th 2012 Alphatec Spine received a complaint which reported that the distal tip of the Trestle Luxe Slide Alignment Tool (Part Number 71721), does not properly fit into the hexalobe screw on the Trestle Luxe Plate. Alphatec Spine, Inc.
Devices Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation. Serial Number: 2DA0882051 Class II 1. It has been found that in raw data processing for Go&Return helical scanning, when the raw data acquired in the first scan (Go) and that acquired in the second scan (Return) are selected and reconstructed at one time, incorrect couch positions and scan times are displayed on the reconstructed images for the data acquired by Return scanning, while all related information is displayed on the reconstructed images for the data acquired by Go scanning. This phenomenon is due to a problem in the image reconstruction software. It should be noted that this error occurs, the error does not occur for in-scan reconstructed images or images obtained by selecting and reconstructing the acquired raw data for each scan individually after scanning is completed. 2. It has been found that when scanning is performed while the tube current is modulated (Sure Exposure 3D), a transmission of the modulation data to X-ray control section may fail due to a hardware problem, and an error occurs at the time of scan setup as a result. If this error occurs at the time of scan setup as a result. If this error occurs, the error message shown in the figure on the right is displayed on the monitor and the eXam Plan is interrupted. In addition, if this error occurs in an eXam Plan in which Sure Exposure 3D is selected as the actual scan for SureStart, the right error message is displayed after monitoring scan. Monitoring scan therefore cannot be switched to the actual scan and the eXam Plan is interrupted as a result. It should be noted that this error does not occur when the tube current is modulated in ECG synchronization. Toshiba American Medical Systems Inc
Biologics Source Plasma 0120597139;0120590536;0120590190;0120589168 0120586695;0120584937;0120584539;0120582630 0120581765;0120580126;0120579149;0120578781 0120577239;0120576214;0120575394;0120575116 0120574297;0120574054;0120573289;0120573072 0120572321;0120572153;0120571209;0120570976 0120569673;0120569301;0120564594;0120546159 0120545371;0120543100;0120540957;0120536887 0120535196;0120533314;0120532463;0120530002 0120528419;0120527706;0120523135;0120523057 0120521616;0120521341;0120519981;0120517362 0120516945;0120515595;0120514242;0120513990 0120509144;0120508031;0120505944;0120505217 0120504120;0120504008;0120503244;0120503144 0120498668;0120498477;0120497398;0120496813 0120496307;0120495869;0120495250;0120494977 0120494217;0120492124;0120491476;0120490909 0120489065;0120487331;0120486061;0120485518 0120484778;0120484519;0120483374;0120482775 0120482626;0120482065;0120481950;0120481397 0120480831;0120479700;0120478351;0120478107 0120475884;0120475585;0120475081;0120474780 0120472786;0120472470;0120471658 Class II Blood products, collected from a donor who was previously deferred, were distributed. CSL Plasma Inc
Biologics Source Plasma 6200120127;6200116213;6200100423;6200099327 6200098074;6200097081;6200096853;95525747 80133612;80131519;80125075;80122722;80114949 80100430;80097570;80092315;80089339;80084402 80082637;80075318;80070610;80069959;80066224 80064152;80060734;80056935;80053286;80043027 80039044;80036777;80030058;80024750;80021964 80017141;79968669;79891554;79881302;79847148 79834650;79821872;79802048;53006622;53003010 52994845;52990441;52979408;52975417;52971778 52967474;52959592;52953552;52946189;52910685 52906268;52895241;95537597;95534459;95529684 95527246;95519203 Class II Blood products, collected from a donor who was previously deferred, were distributed Csl Plasma Inc
Biologics Source Plasma 4270048655, 4270047980, 4270047086, 4270046540, 4270045902, 4270044950, 4270044614, 4270044149, 4270043875, 4270042392, 4270042054, 4270041511, 4270040729, 4270040476, 4270039910, 4270039604, 4270038051, 4270037444, 4270034510, 4270034756, 4270035549, 4270036211, 4270036424, 4270033296, 4270033874, 4270037101, 4270032362, 4270025109, 4270031713, 4270032690, 4270029598, 4270029850, 4270030688, 4270030976, 4270027551, 4270029059 Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Octapharma Plasma, Inc.
Devices ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System. Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) are portable, automated analyzers that measure pH, blood gases, electrolytes, glucose and oximetry (ABL80 FLEX CO-OX only) in whole blood. The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) analyzer systems are intended for use by trained technologists, nurses, physicians and therapists. They are intended for use in a laboratory environment, near patient or point-of-care setting. Model Numbers: 393-839 (with 933-082 software) and 393-841 (with 933-132 software) All Serial Numbers Class II The firm recalled because the glucose measurements from a patient sample that the customer felt was too low and did not reflect the patient's clinical condition. Sendx Medical Inc
Devices Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be connected to 4, 8, or 16 electrode leads or a lead extension. Product Usage: The Eon and Eon Mini Neurostimulation Systems are 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. All lots of the Eon (Product Code 65-3716) Class II As of 11/30/2011, St. Jude Medical has received 110 patient complaints of warmth or heating at the implantable pulse generators (IPGs) implant site during charging for the Eon IPG and 116 reports of similar symptoms for the Eon Mini IPG, respectively. Advanced Neuromodulation Systems Inc.
Devices The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with 4, 8, and 16 electrode leads. Product Usage: The Eon and Eon Mini Neurostimulation Systems are 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. All lots of Eon Mini (Product Code 65-3788) Class II As of 11/30/2011, St. Jude Medical has received 110 patient complaints of warmth or heating at the implantable pulse generators (IPGs) implant site during charging for the Eon IPG and 116 reports of similar symptoms for the Eon Mini IPG, respectively. Advanced Neuromodulation Systems Inc.
Devices Product is labeled in part: "***MEDLINE***Extended PTFE Needle 6.5" (16.51cm) Length***Reorder: ES0016***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0016 -- Lot #: 030608-01 and 121808-19. Product Usage: Intended for cutting and coagulation of soft tissue. Lot #s: 030608-01, 121808-19. Class II On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility. Unimed Surgical Products, Inc.
Devices Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle 4.0" (10.16cm) Length***Reorder: ES0016A***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0016A -- Lot #: 121808-20. Product Usage: Intended for cutting and coagulation of soft tissue. Lot #: 121808-20. Class II On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility. Unimed Surgical Products, Inc.
Devices Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle with Extended Insulation 4.0" (10.16cm) Length***Reorder: ES0016AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0016AM -- Lot #: 062408-08, 062509-01. Product Usage: Intended for cutting and coagulation of soft tissue. Lot #: 062408-08, 062509-01. Class II On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility. Unimed Surgical Products, Inc.
Devices Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle 2.75" (6.99cm) Length***Reorder: ES0013***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0013 -- Lot # 030309-02 and 030509-05 Product Usage: Intended for cutting and coagulation of soft tissue. Lot # 030309-02 and 030509-05 Class II On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility. Unimed Surgical Products, Inc.
Devices Product is labeled in part: "***MEDLINE***Staight Microsurgical Needle 3cm (1.81) Length***Reorder: ESE1651***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ESE1651 -- Lot # 03059-03 Product Usage: Intended for cutting and coagulation of soft tissue. Lot # 03059-03 Class II On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility. Unimed Surgical Products, Inc.
Devices Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle with Extended Insulation 2.75 (6.99cm) Length***Reorder: ES0013M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0013M -- Lot # 042209-02 Product Usage: Intended for cutting and coagulation of soft tissue. Lot # 030509-07, 062309-02. Class II On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility. Unimed Surgical Products, Inc.
Devices Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade 6.5 (16.51cm) Length***Reorder: ES0014***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0014 -- Lot # 042209-03. Product Usage: Intended for cutting and coagulation of soft tissue. Lot # 042209-03. Class II On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility. Unimed Surgical Products, Inc.
Devices Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 4.0 (10.16cm) Length***Reorder: ES0014AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0014AM -- Lot # 050409-05, 050609-05. Product Usage: Intended for cutting and coagulation of soft tissue. Lot # 050409-05, 050609-05. Class II On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility. Unimed Surgical Products, Inc.
Devices Product is labeled in part: "***MEDLINE***Extended 5mm PTFE Coated Ball 5.0 (12.70cm) Length***Reorder: ES0009***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0009 -- Lot # 052709-01 Product Usage: Intended for cutting and coagulation of soft tissue. Lot # 052709-01 Class II On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility. Unimed Surgical Products, Inc.
Devices Product is labeled in part: "***MEDLINE***Standard PTFE Coated Blade with Extended Insulation 2.50 (6.40cm) Length***Reorder: ES0012M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0012M -- Lot # 030509-07, 052909-02, 062309-02. Product Usage: Intended for cutting and coagulation of soft tissue. Lot # 052909-05, 062309-02. Class II On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility. Unimed Surgical Products, Inc.
Devices Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 6.5 (16.51cm) Length***Reorder: ES0014M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0014M-- Lot # 050609-05, 052909-05, 062309-04. Product Usage: Intended for cutting and coagulation of soft tissue. Lot # 050609-05, 052909-05, 062309-04. Class II On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility. Unimed Surgical Products, Inc.
Food Highline Mushrooms Sliced, white mushrooms 8 oz. Size: 8 oz. UPC: 7 71163 00005 2 Lot #: L410805 plus 4-digit time code Date Code: Best Before 12AU15 Class I On 8/13/12, Highline Mushrooms, of Ontario Canada, voluntarily recalled lots of sliced, white mushrooms that may be contaminated with Listeria monocytogenes. Ciolino Wholesale Produce, Inc. received a shipment of the mushrooms and initiated their own voluntary recall upon receiving notice from Highline Mushrooms. Ciolino Wholesale Produce, Inc.
Food Markets of Meijer, fresh Grillers, Mushrooms with Rosemary, 10 oz, Ingredients: Mushrooms, Rosemary, Product of Canada, Keep Refrigerated, Pre-heat grill or over to 450 F... Cook 15-20 minutes in oven/BBQ or 4-5 minutes in microwave... Best By Date August 11th August 26th 2012 UPC code 7-08820-85464-2 Class I As of the August 16, 2012, Pure Hothouse Foods Inc. is voluntarily recalling fresh cut vegetable grilling trays containing mushrooms with the Sell by dates of August 11th, 2012 through August 26, 2012 because they may be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism that can cause serious or life threatening food borne illness in a person who eats a food item contaminated with it. Symptoms of infection may include fever, muscle aches, gastro intestinal symptoms such as nausea or diarrhea. The illness primarily impacts pregnant women and adults with weakened immune systems. Most healthy adults and children rarely become seriously ill. Pure Hothouse Foods Inc.
Food Markets of Meijer, fresh Grillers Steak Toppers, 10 oz, Ingredients: Red Onions, Mushrooms, Product of Canada, Keep Refrigerated, Pre-heat grill or over to 450 F... Cook 15-20 minutes in oven/BBQ or 4-5 minutes in microwave... Best By Date August 11th August 26th 2012 UPC code 7-08820-85468-0 Class I As of the August 16, 2012, Pure Hothouse Foods Inc. is voluntarily recalling fresh cut vegetable grilling trays containing mushrooms with the Sell by dates of August 11th, 2012 through August 26, 2012 because they may be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism that can cause serious or life threatening food borne illness in a person who eats a food item contaminated with it. Symptoms of infection may include fever, muscle aches, gastro intestinal symptoms such as nausea or diarrhea. The illness primarily impacts pregnant women and adults with weakened immune systems. Most healthy adults and children rarely become seriously ill. Pure Hothouse Foods Inc.
Food Markets of Meijer, fresh Grillers Aparagus Blend, 14 oz, Ingredients: Asparagus, Sweet Bell Peppers, Mushrooms,, Sweet White Onions, Product of Canada, Keep Refrigerated, Pre-heat grill or over to 450 F... Cook 15-20 minutes in oven/BBQ or 4-5 minutes in microwave... Best By Date August 11th August 26th 2012 UPC code 7-08820-85353-9 Class I As of the August 16, 2012, Pure Hothouse Foods Inc. is voluntarily recalling fresh cut vegetable grilling trays containing mushrooms with the Sell by dates of August 11th, 2012 through August 26, 2012 because they may be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism that can cause serious or life threatening food borne illness in a person who eats a food item contaminated with it. Symptoms of infection may include fever, muscle aches, gastro intestinal symptoms such as nausea or diarrhea. The illness primarily impacts pregnant women and adults with weakened immune systems. Most healthy adults and children rarely become seriously ill. Pure Hothouse Foods Inc.
Devices Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine, Inc.***www.AtlasSpine.com*** 1555 Jupiter Park Drive #4***Jupiter, Florida 33458***561-741-1108***Tissue Sleeve***MFG Date: XX/XX/XXXX***Lot #: XXXX***Weldment***MFG Date: 03/23/2009***Sleeve Assembly***MFG Date: XX/XX/XXXX***Lot #: XXXX***Qty: 1 Rx Only***Non-Sterile. Sterilize Prior to Use*** Rev. A***. The Modular Screwdriver is used to insert modular pedicle screw implants which are part of the Apelo System. PN# 70175-001 CAT#2006-41-0000 Lot # 00686 Class II Atlas Spine, Inc. recalled their Apelo Modular Screwdriver, a component of the Apelo Pedicle Screw System Instrumentation, because of complaints received about the tip breaking. If the tip is fractured inside of the modular screw, the tip could become implanted in the body or if the entire screw is removed, it could cause a delay in the surgery. Atlas Spine, Inc.
Devices PHADIA VarelisA Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies) Article Number 15696 Lot number #0067 Class III Customers were not following the labeled assay procedure. This was due to a letter issued to them in 2004 from Phadia GmbH, which indicated that customers could omit the pre-wash step. The omission of the pre-wash step, when combined with a change in material source in kit lot #0067, caused elevated results. Phadia US Inc
Devices Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile Abutment Hexed Castable Cylinder***Cylinder; Cylindre; Zylinder; Cilindro; Cilindro; Cilindro***RX only***NON STERILE***Caution: Law prohibits dispensing without prescription***Consult instructions for use*** Castable cylinders are intended to be used to produce a definitive casting for dental restoration onto which porcelain can then be cast. Lots: 2010100001, 2010080684, and 2010090191 Class II Biomet 3i conducted a recall on the device Low Profile Abutment, Non-Hexed Castable Cylinder due to some packages labeled LPCCC1, Hexed Castable Cylinder possibly containing LPCCC2, Non-Hexed Castable Cylinders. Biomet 3i, LLC
Drugs Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20ml, Rx only, Manufactured for: Bracco Diagnostics Inc., Princeton, NJ 08543 USA, NDC 0270-5164-15 Lot S1P272A Expiry Date: December 2014 Class III Short Fill: The product is being recalled due to a potential underfill of the affected vials. Bracco Diagnostic Inc
Food CASS-CLAY, Ice Cream, Artificially Flavored MAPLE NUT, One Gallon (3.78 L), 0 70422 03404 4 HORNBACHERS, MAPLE NUT, Ice Cream, HALF GALLON(1.89 L), 0 41130 21666 4 COLUMBIA VALLEY FARMS, MAPLE NUT, 62438, 3 GALLON(11.34L), 0 41493 62438 0 All products that has a plant code of "38-25". Class I Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared Brazil nuts. Cass Clay Creamery AMPI Fargo Division
Food CASS-CLAY, DOUBLE CHOCOLATE FUDGE, Premium Light Ice Cream, HALF GALLON (1.89L), 0 70422 24061 2 all products that has a plant code of "38-25". Class II Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy lecithin and peanut oil. Cass Clay Creamery AMPI Fargo Division
Food Cass Clay, COOKIES 'N CREAM, 1 gallon ( 3.78 L), 0 70422 45034 9 Cass Clay, COOKIES 'N CREAM, half gallon (1.89 L), 0 70422 04010 6 all products that has a plant code of "38-25". Class II Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy lecithin. Cass Clay Creamery AMPI Fargo Division
Food CASS-CLAY: LIGHT DUSTY ROAD, ONE GALLON (3.78 L), 0 70422 23480 2. LIGHT ICE CREAM, DUSTY ROAD, HALF GALLON (1.89L), 0 70422 24080 3 all products that has a plant code of "38-25". Class II Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy lecithin and wheat. Cass Clay Creamery AMPI Fargo Division
Food HORNBACHERS, LIGHT FRENCH VANILLA, HALF GALLON (1.89L), 0 41130 21662 6 (Missing Egg from Contains statement) SUNNYBROOK, LIGHT FRENCH VANILLA, HALF GALLON (1.89 L), 0 70422 24917 2 . (MISSING YELLOW 5 FROM LABEL) DAN'S, LIGHT FRENCH VANILLA, HALF GALLON(1.89 L), 0 70422 24317 0 (MISSING YELLOW 5 FROM LABEL ) all products that has a plant code of "38-25". Class II Cass-Clay Creamery is voluntarily recalling a number of ice cream products because labelling of egg ingredient is not FALCPA compliant and for undeclared color Yellow 5. Cass Clay Creamery AMPI Fargo Division
Food CASS-CLAY, PRALINE PECAN, 3 GALLON (11.34 L). all products that has a plant code of "38-25". Class II Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared yellow #6, and soy (lecithin). Cass Clay Creamery AMPI Fargo Division
Food CASS-CLAY, BUBBLE GUM, 3 GALLON (11.34 L). all products that has a plant code of "38-25". Class III Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared red 40, Blue 1, and Blue 2. Cass Clay Creamery AMPI Fargo Division
Food CASS CLAY, DULUTH DARK CHOCOLATE, 3 GALLON (11.34 L). all products that has a plant code of "38-25". Class II Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared yellow #5. Cass Clay Creamery AMPI Fargo Division
Food CASS CLAY, NEW YORK CHERRY ICE CREAM, 3 GALLON (11.34 L). all products that has a plant code of "38-25". Class II Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared yellow #5. Cass Clay Creamery AMPI Fargo Division
Food Dan's, LIGHT BUTTER PECAN, half gallon *(1.89 L), 0 70422 24210 4 Hornbachers, LIGHT BUTTER PECAN, half gallon (1.89 L), 0 41130 21661 9 Sunnybrook, LIGHT BUTTER PECAN, half gallon (1.89 L), 0 70422 24908 0 all products that has a plant code of "38-25". Class II Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy (lecithin). Cass Clay Creamery AMPI Fargo Division
Food SunnyBrook, Chocolate Chip one gallon and one quart ( (4.73 L), 0 70422 02905 7 SunnyBrook, CHOCOLATE CHIP half gallon ( (1.89 L), 0 70422 04905 5 Cass Clay, CHOCOLATE CHIP 3 Gallon (11.34 L) all products that has a plant code of "38-25". Class II Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy (lecithin). Cass Clay Creamery AMPI Fargo Division
Food Cass-Clay, UND CHAMPION CHIP, half gallon (1.89 L) 0 70422 04062 5 Cass-Clay, UND CHAMPION CHIP 3 Gallon (11.34 L) all products that has a plant code of "38-25". Class II Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy (lecithin). Cass Clay Creamery AMPI Fargo Division
Food Cass Clay, LIGHT BROWNIE FDG, one gallon ( 3.78 L) 0 70422 23485 7 Cass Clay, LIGHT BROWNIE FUDGE, half gallon (1.89 L) 0 70422 24085 8 all products that has a plant code of "38-25". Class II Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy (lecithin). Cass Clay Creamery AMPI Fargo Division
Food Cass Clay CHOCOLATE MONSTER, half gallon (1.89 L) 0 70422 00032 2 Cass Clay CHOCOLATE MONSTER, 3 Gallon (11.34 L) Soy (Lecithin) N/A all products that has a plant code of "38-25". Class II Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy (lecithin). Cass Clay Creamery AMPI Fargo Division
Food Cass Clay, TIN ROOF SUNDAE 3 Gallon (11.34 L) Cass Clay, TIN ROOF SUNDAE, one gallon (3.78 L), 0 70422 03474 7 all products that has a plant code of "38-25". Class II Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy (lecithin). Cass Clay Creamery AMPI Fargo Division
Food Cass Clay, BISON CRUNCH, half gallon (1.89 L) 0 70422 04033 5 Cass Clay, BISON CRUNCH, 3 Gallon (11.34 L) all products that has a plant code of "38-25". Class II Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy (lecithin). Cass Clay Creamery AMPI Fargo Division
Food Cass Clay, LIGHT CANDY BAR, half gallon (1.89 L ) 0 70422 24032 2 all products that has a plant code of "38-25". Class II Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy (lecithin). Cass Clay Creamery AMPI Fargo Division
Food Cass Clay, LIGHT MUDDY SNEAKERS, half gallon (1.89 L) 0 70422 24072 8 all products that has a plant code of "38-25". Class II Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy (lecithin). Cass Clay Creamery AMPI Fargo Division
Food Cass Clay, PEPPERMINT CANDY, half gallon (1.89 L), 0 70422 00100 8 Cass Clay, Peppermint Stic, 3 Gallon (11.34 L). all products that has a plant code of "38-25". Class II Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy (lecithin). Cass Clay Creamery AMPI Fargo Division
Food Cass Clay, WINTER WONDER, half gallon (1.89 L) , 0 70422 00100 8 Cass Clay, Winter Wonder, 3 Gallon (11.334 L) all products that has a plant code of "38-25". Class II Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy (lecithin). Cass Clay Creamery AMPI Fargo Division
Food Schroeder, Ice Cream, Chocolate Chip Cookie Dough, half gallon (1.89 L), 0 72340 00183 2 all products that has a plant code of "38-25". Class II Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared wheat. Cass Clay Creamery AMPI Fargo Division
Food Hornbachers, Peanut Butter Fudge, Half Gallon, (1.89L), 0 41130-21659 6. all products that has a plant code of "38-25". Class II Cass-Clay Creamery is voluntarily recalling a number of ice cream products because it may contain undeclared peanuts in contains statement. Milk and peanuts listed in ingredient deck, however, only milk listed in contains statement. Cass Clay Creamery AMPI Fargo Division
Food Cass-Clay , Swiss Chip, 3 Gallon(11.34 L). all products that has a plant code of "38-25". Class II Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy (lecithin). Cass Clay Creamery AMPI Fargo Division
Food Cass-Clay, Strawberry Cheesecake, 3 Gallon (11.34 L). all products that has a plant code of "38-25". Class II Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared yellow 5, Yellow 6, Blue 1, Blue 2 and or soy (lecithin). Cass Clay Creamery AMPI Fargo Division
Food CASS-CLAY, Ice cream, LIGHT MAPLE NUT, One Gallon (3.78L), 0 70422 23404 8 all products with a plant code of "38-25". Class I Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared Brazil nuts. Cass Clay Creamery AMPI Fargo Division
Food SUNNYBROOK, LIGHT COOKIES 'N CREAM, half gallon (1.89 L), 0 70422 24943 1 all products with a plant code of "38-25". Class II Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy lecithin. Cass Clay Creamery AMPI Fargo Division
Food Cass-Clay, COOKIES 'N VANILLA 3 Gallon (11.34 L) all products with a plant code of "38-25". Class II Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy lecithin. Cass Clay Creamery AMPI Fargo Division
Food HORNBACHERS, FRENCH VANILLA ICE CREAM, Half-gallon (1.89 L), 0 41130 21658 9 (Missing Egg in the Contains statement) all products with a plant code of "38-25". Class II Cass-Clay Creamery is voluntarily recalling a number of ice cream products because labelling of egg ingredient is not FALCPA compliant. Cass Clay Creamery AMPI Fargo Division
Food Cass-Clay, BUTTER PECAN, 3 Gallon (11.34 L) all products with a plant code of "38-25". Class II Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy lecithin. Cass Clay Creamery AMPI Fargo Division
Devices syngo Imaging XS. Radiological image processing system. Model number 10496279 Class II There is a potential malfunction when using syngo Imaging XS, version VA70A or higher. In some situations it can happen that a miscalculation is done for the grey scale values in the functions "Regions of Interest", "Pixel Lens", "Edge Enhancement" and "Histograms". Siemens Medical Solutions USA, Inc
Devices syngo.plaza, Model number 10592457. Intended use: radiological image processing system. Serial Numbers: 100263, 100401, 100177, 100138, 100174, 100219, 100406, 100249, 200040, 100201, 100198, 100181, 100301, & 100146. Class II There is a potential malfunction in which a miscalculation occurs for images with pixel depth values greater that 12 bit in certain functions. Siemens Medical Solutions USA, Inc
Food Whole Fresh Cantaloupe, PLU# 4319, Burch Farms, Faison, NC 28341. On 8/2/2012 the recall was expanded to include cantaloupes labeled, Cottle Strawberry, Inc., #4319, Faison, NC. (Cottle Farms is not involved in this recall). PLU 4319 Class I Product was found to be contaminated with Listeria monocytogenes. Burch Farms
Food Fresh Whole Honey Dew Melons, packed in paper cartons labeled, Southeastern Growers Association, Fresh Melons. Individual melons were not labeled. None identified (Product shipped between June 23rd and July 27th). Class I Product was found to be contaminated with Listeria monocytogenes. Burch Farms
Food 6" Club Sandwich, 8" Club Sandwich, Club Sandwich Triangle, and Wide Wedge Club Sandwich UPC 697436000058 (6" size); UPC 697436000355 (8" size); UPC 697436000928 (triangle); UPC 697436001437 (wide wedge). Class II The recall was initiated because Rita's Fine Food sandwiches have undeclared milk as a sub-ingredient in cheese. Rita's Fine Food, Inc. Dba Da Vinci's
Food 6" Ham & Cheese Sandwich, 8" Ham & Cheese Sandwich, and Ham & Cheese Triangle Sandwich UPC 697436000065 (6" size); UPC 697436000409 (8" size); UPC 697436000966 (triangle). Class II The recall was initiated because Rita's Fine Food sandwiches have undeclared milk as a sub-ingredient in cheese. Rita's Fine Food, Inc. Dba Da Vinci's
Food 6" Turkey & Cheese Sandwich, Turkey & Cheese Triangle Sandwich, and Wide Wedge Turkey & Cheese UPC 697436000102 (6" size); UPC 697436001000 (triangle); UPC 697436001406 (wide wedge). Class II The recall was initiated because Rita's Fine Food sandwiches have undeclared milk as a sub-ingredient in cheese. Rita's Fine Food, Inc. Dba Da Vinci's
Food 8" Roast Beef Sandwich, 6" Roast Beef Sandwich, Roast Beef Triangle Sandwich, and Wide Wedge Roast Beef Sandwich UPC 697436000454 (8" size); UPC 697436000089 (6" size); UPC 697436000980 (triangle); UPC 697436001420 (wide wedge). Class II The recall was initiated because Rita's Fine Food sandwiches have undeclared milk as a sub-ingredient in cheese. Rita's Fine Food, Inc. Dba Da Vinci's
Food 8" Turkey Sandwich UPC 697436000485 (8" size) Class II The recall was initiated because Rita's Fine Food sandwiches have undeclared milk as a sub-ingredient in cheese. Rita's Fine Food, Inc. Dba Da Vinci's
Food Wide Wedge Ham Sandwich UPC 697436001413 (wide wedge). Class II The recall was initiated because Rita's Fine Food sandwiches have undeclared milk as a sub-ingredient in cheese. Rita's Fine Food, Inc. Dba Da Vinci's
Food 8" Meatball Sandwich UPC 697436000416. Class II The recall was initiated because Rita's Fine Food sandwiches have undeclared milk as a sub-ingredient in cheese. Rita's Fine Food, Inc. Dba Da Vinci's
Food Medium Chef Salad UPC 697436001833. Class II The recall was initiated because Rita's Fine Food sandwiches have undeclared milk as a sub-ingredient in cheese. Rita's Fine Food, Inc. Dba Da Vinci's
Food Pita Pocket Club Sandwich UPC 697436000645 Class II The recall was initiated because Rita's Fine Food sandwiches have undeclared milk as a sub-ingredient in cheese. Rita's Fine Food, Inc. Dba Da Vinci's
Food Pita Pocket Turkey & Cheese UPC 697436000706 Class II The recall was initiated because Rita's Fine Food sandwiches have undeclared milk as a sub-ingredient in cheese. Rita's Fine Food, Inc. Dba Da Vinci's
Food Pita Pocket Ham & Cheese UPC 697436000676 Class II The recall was initiated because Rita's Fine Food sandwiches have undeclared milk as a sub-ingredient in cheese. Rita's Fine Food, Inc. Dba Da Vinci's
Food Pita Pocket Roast Beef Pita Pocket Roast Beef UPC 697436000683 Class II The recall was initiated because Rita's Fine Food sandwiches have undeclared milk as a sub-ingredient in cheese. Rita's Fine Food, Inc. Dba Da Vinci's
Devices DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The product is used during ablation surgical procedures. ACT1020, 168583 through , 210055X; ACTC1525, 168575 through, 208115X; ACT1030, 171291 through , 209598X; ACTC2025, 168853 through, 209457X; ACT1507, 168576 through, 209455X; SWCT1530, 170383 through, 210057X; ACT1510, 170882 through , 207901X; SWCT15303, 169683 through, 207900X; ACT1520, 168571 through, 210054X; SWCT1540, 170384 through, 197330; ACT1530, 169419 through, 209547X; SWCT20303, 191407 through,  ...
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Class II Covidien is conducting a recall of various production lots of DGHP RFA High Power single use grounding pads and Cool-tip RFA Electrode Kits due to the potential for foil degradation on the DGP-HP single use grounding pad which may result in an electrical burn to the patient at the application site. Nellcor Puritan Bennett Inc. (dba Covidien LP)
Devices Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry Versions 6.4 and later Class II The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory versions 6.4 and later while using Microbiology Result Entry (MRE), the specimen ribbon containing the Accession Number (AN) and the Battery Name may be missing or contain the wrong information. Sunquest Information Systems, Inc.
Devices Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 The Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDMR CalPak), Catalog No. CDDMR-C is an in-vitro diagnostic product intended to be used for the calibration of the Stratus(R) CS Acute Care(TM) D-dimer )DDMR) method DDMR CalPak lots 502058002, exp 2012/11/23 and 501318002, exp 2012/08/10 Class III Siemens has confirmed that the Stratus(R) CS Acute Care(TM) D-Dimer CalPak calibrator lots 502058002 and 501318002 may exhibit SLOPE or CALCV error messages (instrument errors), which indicate calibration failures. Siemens Healthcare Diagnostics, Inc.
Devices Sunquest Laboratory LabAccess Results Workstation (LARS) Sunquest Laboratory versions 5.3.3 and 6.3.0 SP3 Class II The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory LabAccess Results Workstation (LARS) may file results to the wrong patient by incorrectly combining results. Sunquest Information Systems, Inc.
Devices OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; and ConneCTstat Plus picture archiving and communications systems. The systems are an aid to locate anatomical structures during open or percutaneous surgical procedures. It is intended for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MRI, or X-ray. All serial numbers. Class I GE Healthcare Surgery had discovered that using the Inverted Headset Placement is not a validated configuration with the IT 3000, 2500, 2500 plus, 3500, 3500 plus, ConneCTstat, and ConneCTstat Plus Surgical Navigation equipment. GE OEC Medical Systems, Inc
Food GREEN CHILE CHICKEN ENCHILADAS 12 OZ UPC: 20212400000 Distributed: 07/20/2012 through 07/27/2012 Class I Our product was recalled because one of the ingredients used was subject to the Gills Onion 07/25/2012 onion recall . That ingredient was sold to us from Sysco Detroit. Busch's, Inc. - Central Production Facility
Food POTATO CKS ORIGINAL BM 1 EA UPC: 20234100000 Distributed: 07/20/2012 through 07/27/2012 Class I Our product was recalled because one of the ingredients used was subject to the Gills Onion 07/25/2012 onion recall . That ingredient was sold to us from Sysco Detroit. Busch's, Inc. - Central Production Facility
Food POTATO CKS SWEET BM 1 EA UPC: 20235100000 Distributed: 07/20/2012 through 07/27/2012 Class I Our product was recalled because one of the ingredients used was subject to the Gills Onion 07/25/2012 onion recall . That ingredient was sold to us from Sysco Detroit. Busch's, Inc. - Central Production Facility
Food BUSCHS SHEPHERD'S CHICKEN PIE 14 OZ UPC: 20243200000 Distributed: 07/20/2012 through 07/27/2012 Class I Our product was recalled because one of the ingredients used was subject to the Gills Onion 07/25/2012 onion recall . That ingredient was sold to us from Sysco Detroit. Busch's, Inc. - Central Production Facility
Food 1/2 PAN BAKED MOSTACCIOLI BM 1 EA UPC: 20308400000 Distributed: 07/20/2012 through 07/27/2012 Class I Our product was recalled because one of the ingredients used was subject to the Gills Onion 07/25/2012 onion recall . That ingredient was sold to us from Sysco Detroit. Busch's, Inc. - Central Production Facility
Food 1/2 PAN BAKED MEAT LASAGNA BM 1 EA UPC: 20314900000 Distributed: 07/20/2012 through 07/27/2012 Class I Our product was recalled because one of the ingredients used was subject to the Gills Onion 07/25/2012 onion recall . That ingredient was sold to us from Sysco Detroit. Busch's, Inc. - Central Production Facility
Food BUSCHS JAMBALAYA WITH SHRIMP B 13 OZ UPC: 20578200000 Distributed: 07/20/2012 through 07/27/2012 Class I Our product was recalled because one of the ingredients used was subject to the Gills Onion 07/25/2012 onion recall . That ingredient was sold to us from Sysco Detroit. Busch's, Inc. - Central Production Facility
Food BUSCHS QUESADILLA CHICKEN BM 1 EA UPC: 20769100000 Distributed: 07/20/2012 through 07/27/2012 Class I Our product was recalled because one of the ingredients used was subject to the Gills Onion 07/25/2012 onion recall . That ingredient was sold to us from Sysco Detroit. Busch's, Inc. - Central Production Facility
Food BUSCHS BURRITO CHICKEN BM 12 OZ UPC: 20901800000 Distributed: 07/20/2012 through 07/27/2012 Class I Our product was recalled because one of the ingredients used was subject to the Gills Onion 07/25/2012 onion recall . That ingredient was sold to us from Sysco Detroit. Busch's, Inc. - Central Production Facility
Food BUSCHS DOWN HOME LASAGNA BM 14 OZ UPC: 20917500000 Distributed: 07/20/2012 through 07/27/2012 Class I Our product was recalled because one of the ingredients used was subject to the Gills Onion 07/25/2012 onion recall . That ingredient was sold to us from Sysco Detroit. Busch's, Inc. - Central Production Facility
Food BUSCHS SPAGHETTI & MEATBALLS B 14 OZ UPC: 20919100000 Distributed: 07/20/2012 through 07/27/2012 Class I Our product was recalled because one of the ingredients used was subject to the Gills Onion 07/25/2012 onion recall . That ingredient was sold to us from Sysco Detroit. Busch's, Inc. - Central Production Facility
Food BUSCHS SOUP FROM FOOD BAR Random weight/Sold by the pound UPC: 20919100000 Distributed: 07/20/2012 through 07/27/2012 Class I Our product was recalled because one of the ingredients used was subject to the Gills Onion 07/25/2012 onion recall . That ingredient was sold to us from Sysco Detroit. Busch's, Inc. - Central Production Facility
Food Jakes Spice Drop, Jake's Jelly Spice Drops 3oz, 4.5oz, 5oz, 6oz and 7oz packages Distributed by Jake's Liberty Packaging Oak Park, MI 48237 248-747-2223 Packaging is labeled with a best buy date of 1 year from repackaging date. Class II New York State Department of Agriculture sampled the product and found undeclared colors in Jakes Candy Spice Drops. The firm was notified on 4/19/2012 via letter from New York. FDA conducted follow up and associated inspections on 6/29/12, 7/26/12 and 7/27/12 and determined the labels continued to have the undeclared colors, including FD & C Red 40, Yellow 6, Blue1 and Red 3. Four Brothers Packaging Corporation
Drugs Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for Direct Infusion, For Intravenous Use, Rx only, a) 50 mL Single Dose Vial, b) 100 mL Single Dose Vial, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Nycomed GmbH, 78224 Singen (Germany), NDC a) 0270-5264-16, b) 0270-5264-17. Lot #: a) 9J37457, 9J44058, Exp 10/12; b) 9I28973, Exp 09/12 Class II Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage. Bracco Diagnostic Inc
Drugs Eco-Dent Sparkling Clean Mint Ultimate Essential MouthCare, Natural Daily Rinse and Oral Wound Cleanser/Oral Debriding Agent, 8 fl oz (237 mL) bottle, Alcohol Free, Dist By: Eco Dent, 1100 Lakes Dr., Silver Lake, WI 53170 USA, UPC Code: 00037541 Lot #: 4052, Exp 01/15; 4063, Exp 02/15; 4150, Exp 03/15. Class II Microbial Contamination of Non-Sterile Products; Product was found to be contaminated with Sphingomonas paucimobilis bacteria. Capco Custom Packaging Inc
Food UNH Stir Fry: 5 lbs ply bag Broccoli. Bock Choy. Spanish Onions (1" x 1" cut). Celery Packed by: fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129 Item # 00137 Produced on: 7/20/12, 7/24/12, 7/25/12 Class I Products contain recalled Gill's Onions due to Listeria monocytogenes Fresh Ideas Inc.
Food Costa 1/16" Sliced Onions, 5 lb poly bag (Item # 00254); Costa 1/4" Sliced Onions, 5 lb poly bag (Item #C50) Packed by: Fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129 Produced on: Between 7/18/12, and 7/25/12 Class I Products contain recalled Gill's Onions due to Listeria monocytogenes Fresh Ideas Inc.
Food Costa Kabob Cut White Onions 1" x 1", 5 lb poly bag (Item #00275) Packed by: Fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129 Produced on: Between 07/18/12 and 7/25/12 Class I Products contain recalled Gill's Onions due to Listeria monocytogenes Fresh Ideas Inc.
Food Costa Whole Peeled Onions (Item #00841, #B841) 25 lb poly bag Packed by: Fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129 Item # 00254 Produced On: Between 7/18/12, and 7/25/12 Class I Products contain recalled Gill's Onions due to Listeria monocytogenes Fresh Ideas Inc.
Food Costa: 1/2" Diced Onions (Item #C228); 3/4" Diced Onions (Item #C244) 1/4" Diced Onions (Item#C32) 5 lb poly bags Packed by: Fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129 Legal Seafood Diced Onions 1/16" (Item #L163) 10 lb poly bag OB Double Diced Onions 1/8" (item #OB2), 2 lb poly tub Produced on: Between 7/18/12 and 7/25/12 Class I Products contain recalled Gill's Onions due to Listeria monocytogenes Fresh Ideas Inc.
Food Small Soup Vegetable Mix:-(Item #CC4) Spanish Onions {1/4" dice), Carrots, Celery Medium Soup Mix Vegetables (Item #CC5) Spanish Onions (1/2" dice), Carrots. Celery 5 lb poly bags Packed by: Fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129 Item # 00254 Use By: 7/19/12, 7/20/12, 7/21/12, 7/22/12, 7/24/12, 7/25/12 Class I Products contain recalled Gill's Onions due to Listeria monocytogenes Fresh Ideas Inc.
Food Julienne Onions, Item #J705 4.0 lbs poly tub; Legal Onion Strings (Item #L165), 5 lb poly bag Packed by: Fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129 Item # 00254 Produced on: 7/21/12, 7/22/12, 7/24/12, 7/25/12 Class I Products contain recalled Gill's Onions due to Listeria monocytogenes Fresh Ideas Inc.
Food Costa Asian Stir- Fry Blend (Item #SAL3) 5 lb poly bag Spanish Onions {1/4" Sliced), Red Onions, Green Peppers. Red Peppers, Zucchini, Carrots, Broccoli, Broccoli Stems, Green Cabbage, Pea Pods, Bok Choy Packed by: Fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129 Produced on: 7/18/12, 7/21/12, 7/24/12, 725/12 Class I Products contain recalled Gill's Onions due to Listeria monocytogenes Fresh Ideas Inc.
Food Costa Four Bean Salad 4.50 lbs Poly Tub (Item #01385 Green Beans, Kidney Beans (kidney beans, water, salt, CaCI2), Chick Peas (chick peas. water. salt, EDTA to promote color retention), Black Eyed Peas (black eye peas, water, salt, calcium chloride and disodium EDTA to preserve color). White Onions, Red Peppers , Italian Dressing (distilled vinegar. soy bean oil. water, com syrup, salt, onion. red bell pepper. xantham gum, spice and oleo resin paprika, calcium disodium EDTA), Red Peppers (peppers, water, sugar. salt, citric acid, CaCI2). Onion. While Vinegar and Garlic Powder Use By: 7/26/12, 7/27/12, 8/2/12 Class I Products contain recalled Gill's Onions due to Listeria monocytogenes Fresh Ideas Inc.
Food Calico bean Salad 5 lbs Poly Tub (Item #01409) packaged under Costa and Stop & Shop brand, Item T1407, C1407, 5 lb Poly Bag Black eye peas , water, salt, calcium chloride and disodium EDTA to preserve color), Chick Peas (cooked dried chick peas, water,salt), Kidney Beans (kidney beans, water. salt, CaCI2), Black Beans (black beans, water. salt, CaCI2, ferrous gluconate), Italian Dressing (distilled vinegar, soy bean oil, water, com syrup,salt. onion, red bell pepper, xantham gum. spice and oleo resin paprika, calcium disodium EDTA). Apple Cider Vinegar, Celery, Green Pepper, Red Pepper, Onion Use By: 7/26/12, 7/27/12, 7/31/12, 8/2/12 Class I Products contain recalled Gill's Onions due to Listeria monocytogenes Fresh Ideas Inc.
Food Costa Multiple Bean Salad 4.5 lbs Poly Tub (Item #01407) Black Beans (black beans, water. salt, calcium chloride, ferrous gluconate), Kidney Beans (kidney beans, water. salt, CaCI2), Black Eyed Peas(blackeye peas. water, sail. calcium chloride and disodium EDTA to preserve color). Chick Peas (chick peas, water, salt, EDTA to promote color retention), Italian Dressing (distilled vinegar. soy bean oil, water, com syrup, salt, onion, red bell pepper, xantham gum, spica and oleo resin paprika, calcium disodium EDTA), Red Peppers (peppers, water, sugar, salt, citric acid, CaCI2), Onion, White Vinegar and Garlic Powder Use By: 7/26/12: 7/31/12, 8/2/12 Class I Products contain recalled Gill's Onions due to Listeria monocytogenes Fresh Ideas Inc.
Food Fajita Mix-Red Pepper, Green Pepper, Spanish Onion {1/4" Sliced) Item #SAL4, 5 lb poly bag Produced on: 7/18/12, 7/21/12, 7/24/12, 7/25/12 Class I Products contain recalled Gill's Onions due to Listeria monocytogenes Fresh Ideas Inc.
Food Tex Mex Sliced Vegetable Blend, Item #TMEX Red Pepper, Green Pepper, Spanish Onion {1/4" Sliced) 5 lb poly bag Produced on: 7/18/12, 7/21/12, 7/24/12, 7/25/12 Class I Products contain recalled Gill's Onions due to Listeria monocytogenes Fresh Ideas Inc.
Food Amy's Brand Pizza Pesto Made with Organic Vegetables & Basil in 7 oz; ; 13.5 oz; Sku# 42272-00104 Product is processed and packaged by Amys Kitchen, White City, Oregon 7 oz: Best Before July24 2012; Lot Code: 30-G242, sku# 42272-00197; 13.5 oz Best by 7/17/12, Lot No. 30-G172; 383 grams, best by 7/17/12, Lot No. 30-1992AK and best by 7/18/12, Lot No. 30-2002AK (French labeling) Class I Product contains undeclared peanut in the ingredient statement (Peanuts were found in pinenuts). Amy'S Kitchen
Food Trader Giotto brand Pesto Pizza in 13.5 oz; SKU# 00539937; Product is processed and packaged by Amy's Kitchen, White City, Oregon Best Before July 17, 2012 and July 18, 2012; Lot Code: 30-1992AK and 30-2002AK Class I Product contains undeclared peanut in the ingredient statement (Peanuts were found in pinenuts). Amy'S Kitchen
Drugs Oasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06%, 473 mL (16 fl oz) bottle, Oasis Consumer Healthcare LLC, 812 Huron Road, Cleveland, Ohio 44115, UPC 8 51076 00300 2. Lot #: 11741, 11842, 11851, Exp 05/14 Class III Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia. Natural Essentials Inc
Food Frozen Pangasius Fish, brand name T&T, in the following sizes: a. IQF 15 lbs bulk carton: 3/5 oz, 5/7 oz, 7/9 oz, 9/11 oz b. 11lbs x 2 per carton: 8/10 oz and 10 oz/up c. 2lbs x 5 per carton: 2/3 oz d. 15lbs carton: 2/3 oz Product labeling reads in part:" T&T SWAI ROSE ROLL(Pangasius hypophtalmus)***FARM-RAISED PRODUCT OF VIETNAM***". Packaged in paper box carton. For IQF 15 lbs bulk, lot numbers: 070S8 070C9 071C6 071C7 071C5 071S5 071C8 072S7 072S9 072S8 072S4 072S5; For 11lbsx2 cartons: 054S; For 2lbsx 5 cartons: 070C3 and 070C4; For 15 lbs cartons: 070S7 Class III The product was recalled because nitrofuran residue was detected. Nha Trang Seafoods, Inc
Food Dippin' Stix Sliced Apples & Caramel with Peanuts USE BY dates 01SEP2012, 02SEP2012, and 03SEP2012 Class I Reichel Foods is recalling these products because the sliced apples have the potential to be contaminated with Listeria monocytogenes. Reichel Foods, Inc
Food Apple Slices & Fat Free Caramel Dip contained in the Armour Active Packs Cheese Pizza Lunch Kit Package code 1026090112 Class I Reichel Foods is recalling these products because the sliced apples have the potential to be contaminated with Listeria monocytogenes. Reichel Foods, Inc
Devices ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a Flow and ONDEMAND Model/Reference #: 7000180, 7000181, 7000182, 7000367, 7000397, CB003, CB005, CB006, P400X1-7+5/60, P400X2-14+5/30, P400X5+5/60, and PMB01. Part Numbers: 101347100, 101347300, 101347400, 101360200, 101368400, 101368600, 101368700, 102987000, 102987200, 102987300, 103161800, 103534300, 5001438, 5001470, 5001651, 5001780, 5001808, 5001809, 5001812, 7000180, 7000181, 7000182, & 7000367. Indicated for continuous and or intermittent delivery of medication to or around surgical wound sites and or close proximity to nerves. Products having a 10-digit Lot # that is greater than 0200521454 (i.e. 0200521455 and greater) are not impacted by this recall. Class I It was determined that in a small quantity of ON-Q pumps with ONDEMAND, the bolus button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lowermost position. As a result, the patient may receive continuous infusion at a rate greater than expected. I-Flow Corporation
Devices Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9; Product is manufactured and distributed by Cisco Systems, Inc. San Jose, CA Cisco HealthPresence, version 2 is intended for remote consultation of patients with a healthcare provider. Cisco HealthPresence enables remote collaboration between a physician and a patient by providing: high-definition video and advanced audio; transmission and display of third-party medical device data; integration with third party EMR: scheduling: and other software applications for remote consultations and exams. Cisco Health Presence is not intended for use in emergency situations. Cisco HealthPresence is not intended for use in active patient monitoring or alarming. Serial/Code Number: 2.1.0.87 Class II Software anomaly may result in incorrect values and interpretations. The initial vital signs reading will display accurately on the Cisco Health Presence Vitals tab and the OnePlace tab. However, subsequent vital signs readings will only update on the Cisco HealthPresence Vitals tab and within the OnePlace database, but will not update under the OnePlace tab, and thus, will not provide current vital signs on the OnePlace display, unless the OnePlace tab is manually refreshed by the user. Cisco Systems Inc
Devices QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor. Lot numbers: 1879717, 1943786, 2054914, 2143717, 2177723, 2342319, 2730752, 2922565, 3094190 Class II STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtain two (2) of the needed devices; these two devices represent the design of seven (7) models in one quick connect. Due to the unavailability of these two validation devices, STERIS will remove 7 models from the labeling of QKC1692E and will re-label all QKC1692Es in the field.. Steris Corporation
Drugs CosMedix Serious Protection, Natural SPF 28 Sunscreen, 3.3 fl.oz/100mL (100 g), Distributed by CosMedix, LLC, Atlanta, GA --- Also labeled as RESULTS RX, Serious Protection Rx, SPF 28 Sunscreen, Net Wt. 4oz/120g. Batch # P030911C, Exp 03/13; Batch # P022811A, Exp 02/13. Class II Microbial Contamination of Non Sterile Product; mold Island Kinetics dba Covalence
Devices 16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer. The device is used for patients requiring hemodialysis. The HemoStar XK catheter is made of radio-opaque polyurethane and allows for flow rates as high as 500 ml/min during hemodialysis treatment. Product Code 5883730 lot number REVK0125. Class III Bard Access Systems is recalling one lot of 16 Fr HemoStar XK Long Term Hemodialysis Catheters because they were identified with an incorrect expiration date, 03/2015 rather than 10/2013. Bard Access Systems
Food Yogurt Parfait Strawberry, Net weight 9 oz. (225 g), UPC 0 20728 70004 4. Product contains yogurt and strawberry filling and one cup of granola, packaged in a clear container, and granola is in the inner container. The product is labeled in part: '***YOGURT PARFAIT STRAWBERRY***9oz (225g)***Distributed by PACIFIC COAST FRUIT CO***Portland, OR 97267*** Expiration dates: 8/10 and 8/12 Class II The Yogurt Parfait Strawberry contains coconut, but the label does not declare coconut. Shin Shin Foods, Inc.
Food Aussie-Style Lucky Country Soft Licorice in 1.5 lb. bags. The product is packaged 1.5lb x 18 bags per tray. Lot A3057, UPC Code 817795000944 Class II Lead contamination Lucky Country, Inc.
Drugs Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered Inhalations, FOR ORAL INHALATION ONLY - For use with Ventolin HFA actuator only. Net. wt. 18 g Rx only, GlaxoSmithKline, Reasearch Triangle Park, NC 27709 NDC 0173-0682-20 Lot 1ZP7355 Exp. 01/13, 1ZP7749 Exp. 01/13, 1ZP8141 Exp. 01/13, 1ZP8147 Exp. 01/13, 1ZP7729 Exp. 01/13, 1ZP0414 Exp. 03/13, 1ZP0464 Exp. 03/13, 1ZP0570 Exp. 03/13, 1ZP0576 Exp. 03/13, 1ZP0919 Exp. 03/13, 2ZP4959 Exp. 04/13, 2ZP4966 Exp. 04/13 Class II Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification. GlaxoSmithKline Inc
Devices 3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along lateral condyle. This insert is to be used along with the other components that comprise the 3DKnee System. Model Number 392-09-706, Lot Number 59602519 Class II The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The shelf life labeling of specific lots for a component were found to be incorrect and were found to be expired. Encore Medical, Lp
Drugs Capex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For Topical Use Only, 4 fl oz in a 6 oz bottle, Marketed by: Galderma Laboratories, LP, Fort Worth, TX, Mfd. by: Hill Dermaceuticals, Inc., Sanford, FL --- NDC 0299-5500-04, Lots J090181-H100089, J090181-J100096, and J090181-K100102. Class III Subpotent; fluocinolone acetonide. Galderma Laboratories, L.P.
Devices Canon Solid Stale X-ray Imaqer (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. Catalog numbers 3930B002AA, 3928B002AA, and 4066B002AA. Class II Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor. Canon Inc.
Devices Toshiba CT systems, Asteion and Aquilion, that are equipped with a PC based computer, or to those older systems (SGI based) that received an improved table by an upgrade purchase. This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstruction!;, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared devices already found in the marketplace. Serial Number Range (last 4): (2665-3149), (2211-2237), (2057-2067), A3622041, A4582122 + (2690-3131), (2001-2171), (2001-2124), (2001-2255), (2001-3007), (2015-2061), (2001-2008). The following Device Name/Model Number: Asteion Super 4 / TSX-021B Aquilion Super 4 / TSX-101A/7 Aquilion 8 / TSX-101A/F Aqui1ion 16/ TSX-101A/6 Aqui1ion 16/ TSX-101A/G Aquilion 32 / TSX-101A/D Aquilion 32 / TSX-101A/I Aquilion 64/TSX-101A/E Aquilion 64 / TSX-101AIH Aquilion 16 LB /  ...
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Class II The systems all have a similar table control board. It has been found that this board may cause the table position to be incorrect if the table cradle is moved manually. This is referred to as "Free" mode in the operation manuals. If this error does occur it is possible that the patient could be scanned at an incorrect position. Toshiba American Medical Systems Inc
Devices EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, MR Angiography/MR Vascular Imaging, Blood Oxygenation Level Dependent Imaging, Perfusion I Diffusion Imaging, and Proton Spectroscopy. Models MRT-1503 and MRT-1504 " MRT-1503 systems with software V9.01 *R240 through V9.20*R242 " MRT-1504 systems with software V9.21 *R24 Class II The status display in the sequence queue window may not change from "Current" to "Done". Toshiba American Medical Systems Inc
Devices CaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. Alternate brands: EnviroCide, part number: 13-3325. Private labeled products of Cavicide: Backscratchers Cavicide, part number: 13-4800. MaxiSpray Plus, part numbers: 13-7400 and 13-7405. pdCARE Surface Disinfectant, part numbers: 13-7525 and 13-7500. Z3 Surface Disinfectant, part number: 13-7900. CaviCide is a multi-purpose disinfectant/decontaminant cleaner for use on hard, non-porous inanimate surfaces. CaviCide is a bactericidal, virucidal, fungicidal, and tuberulocidal which is available in a ready-to-use, liquid form typically contained in 1 gallon bottles, 2.5 gallon bottles, 25 oz. spray bottles, or 55 gallon drums (depending on the item number). CaviCide may also be branded as a private label (see (1)(vi) below for names and Table 1 above for additional details). The product may be used (1) for precleaning non-instrument surfaces prior to disinfection; (2) for precleaning instruments prior to disinfection; (3) as a virucide on non-instrument surfaces; (4) as a disinfectant on non-instrument surfaces; (5) as a virucide on precleaned non-critical medical devices, instruments and implements; and (6) as a disinfectant on precleaned non-critical medical devices, instruments, and instruments. It is useful in health care settings such as hospitals, emergency medical settings, surgical centers, isolation areas, neonatal units, patient care areas, ophthalmic and optometric facilities, dental offices, dental operatories, animal care facilities, salon settings, emergency vehicles, schools, health club facilities, kitchens, bathrooms, prisons, morgues, and other critical care areas. CaviCide Lot # 10-1301, 10-2301, 10-2302, 10-2328, 10-2328A, 10-2328B, 10-2331, 10-2333, 10-1334, 10-2334, 10-1335, 10-2335, 10-1342A, 10-1343, 10-2345. EnviroCide Lot # 10-2331. Backscratchers Cavicide lot # 10-1342. MaxiSpray Plus lot # 10-2328A and 10-1343. pdCARE Surface Disinfectant lot # 10-2331 and 10-2345. Z3 Surface Disinfectant lot # 10-2328. Class II Metrex Research is recalling Cavicide containing the Spring Fresh Fragrance because the affected lot of product containing this fragance has caused an increase in reported health reactions in some individuals such as headache, nausea, and respiratory discomfort. Metrex Research, LLC.
Devices Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277, VS2+ 863278, 863279. The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility. The SureSigns VSi vital signs monitor is for measurement of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility Serial Number Range CN14800101-CN14801360 CN21201362-CN21202440, CN21202525, SP13701043, USPP101007 Class II Philips SureSigns VSi/VS2+ patient monitors may not be properly secured and may fall from the wall mount Philips Healthcare Inc.
Food Organic Pinenuts. 5lb bag: Organic Pine nuts packed into plastic bag with a twist tie with a White stick on label with hand written product description. 27.5lb bag: Organic Pine nuts inside of a plastic bag with a white stick on label with typed product description. Lot 40034 and all organic pinenuts distributed between March 22, 2012 to August 14, 2012 Class I Organic Pinenuts are recalled due to potential contamination of peanuts or traces of peanuts. Honey Heaven Wholesale, Inc.
Devices V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for Use for the V Series include the monitoring of the following human physiological parameters: ECG waveform derived from 3, 5, 6 and 12 lead measurements; Heart Rate; Pulse Oximetry (SpO2); ST Segment Analysis; Arrhythmia Detection; Non Invasive Blood Pressure (NIBP); Invasive Blood Pressure (IBP); Cardiac Output (CO); Respiratory Gasses; Respiration Rate; and Temperature. The V Series Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. The target populations are adult, pediatric and neonate with the exception of: Arrhythmia detection and ST Segment Analysis, for which the target populations are adult and pediatric only; IV Drug Calculations for which the target population is adult only; and Cardiac Output for which the target population is adult and pediatric only. V Series Monitor Part Numbers 0998-00-1800-101 and 0998-00-1800-201. Class II Mindray has identified two software anomalies contained in the V Series Monitoring System. There have been no reports of injuries associated with these anomalies. These anomalies affect V Series Systems distributed between September 31, 2010 and January 9, 2012. Mindray DS USA, Inc. d.b.a. Mindray North America
Devices Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated syringe infusion pump; Product Usage: These product codes includes refurbished units. Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician. Usage: The Mini-Infuser System is designed for controlled intermittent administration of intravenous medication. product codes 2M8170 and 2M8170R, all serial numbers Class III Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (.53 inches), an electrical circuit will not be completed and the Mini-Infuser will not operate. The reason being that the Mini-Infuser Battery Spring has a flat contact that measures .53 inches ±.01 inches on the inner diameter of the spring coil. The IEC 60086-2 and ANSI 08 standards specify a minimum of .51 inches for the negative terminal diameter. Baxter Healthcare Corp.
Devices Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syringe infusion pump with an active time scale and rate selector switch; product codes 2M8171 and 2M8171R. Product Usage: These product codes includes refurbished units. Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician. Usage: The Mini-Infuser System is designed for controlled intermittent administration of intravenous medication. product codes 2M8171 and 2M8171R, all serial numbers Class III Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (.53 inches), an electrical circuit will not be completed and the Mini-Infuser will not operate. The reason being that the Mini-Infuser Battery Spring has a flat contact that measures .53 inches ±.01 inches on the inner diameter of the spring coil. The IEC 60086-2 and ANSI 08 standards specify a minimum of .51 inches for the negative terminal diameter. Baxter Healthcare Corp.
Food Pico de Gallo salsa, 2 lbs pouch, packaged in a case of 5/2 lbs. Product labeling reads in part:" REAL MEX FOODS ITEM # 15102 "MILD" PICO DE GALLO*** PACK SIZE: 5/2 LBS. NET WEIGHT: 10 LBS Real Mex Foods 3305 Vernon Ave. Vernon, Ca 90058***". Use by 08/20/12 and 08/21/12. Item number 15102. UPC 7 58897 15102 1. Class I The firm recalled because products manufactured used the cilantro recalled by their supplier has the potential to be contaminated with Salmonella. Real Mex Foods
Food Cheese and red onion enchilada, 2 oz packaged in 240/2oz case, net weight 30 lbs. Product labeling reads in part:" REAL MEX FOODS Item # 14800 CHEESE & RED ONION ENCHILADA***KEEP REFRIGERATED*** PACK SIZE: 240/2 OZ. NET WEIGHT:30.00 LBS Real Mex Foods 3305 E. Vernon Ave. Vernon, Ca 90058.***" Use by date 08/24/12, Item # 14800, UPC 7 58897 14800 Class I The firm recalled because products manufactured used the cilantro recalled by their supplier has the potential to be contaminated with Salmonella. Real Mex Foods
Drugs METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, This cup delivers 10 mL, Rx Only, Manufactured by VistaPharm, Inc., Largo FL33771 195900 exp. 01/12. Class III Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," instead of "10 mL x 50," VistaPharm, Inc.
Food Tanimura & Antle Romaine Lettuce (Laitue Romaine) in plastic bag Wrapped Single Head Romaine marked Field Packed for Freshness.. Distributed by Tanimura & Antle, Salinas, CA. May have a best buy date of 8/19/12 and available at retail locations from August 2 to 19, 2012. Class I FDA was notified by CFIA of a positive result for E-cole O157:H7 in Romaine Lettuce with the brand name of Tanimura & Antle, Salinas, CA. Tanimura & Antle
Food SunFresh Natural Fruit & Nut, Distributed by: Sunfresh Natural, LLC. Passaic, NJ 07055. Please visit us at: www.sunfreshnatural.com. 6 ounce and 10 ounce packages (Net wt.). Net wt. 6 ounce (plastic bag) and 10 ounce (rigid plastic container). Class II SunFresh Natural 6 ounce Fruit & Nut product label does not list sulfites and FD&C Yellow #6 ingredients. SUNFRESH NATURAL LLC.
Devices CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and manual cleaning and disinfection. Product codes: 20390 (US), 20391 (EMEA and WW), 20394 (Canada), and 20690 (Korea). Class II The recall was initiated because Advanced Sterilization Products has discovered instances of missing labels on bottles of CIDEX OPA Solution, Part # 20390 manufactured between May 2011 and April 2012. Advanced Sterilization Products
Drugs Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, NDC 60505-0833-5. Lot #: JK9130, JM0925, Exp 05/12; JN6514, Exp 07/12; JN1125, JN1127, Exp 08/12; JR5780, JR5782, Exp 12/12. Class III CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product. Apotex Corp.
Food Dole Italian Blend; Romaine, Radicchio; 10 oz plastic bag (283g); UPC:7143000819. Dole, Monterey, CA 93942. Code number 0049N2202008. Best by Date of August 20, 2012. Class I USDA MDP program collected samples of finished product Dole Italian Blend and had positive sample results for Listeria Monocytogenes. Dole Fresh Vegetables Inc
Food Naturally Fresh Salad Toppings, Roasted & Glazed Pecan Pieces, Net weight 3.5 oz, Distributed by: Naturally Fresh, Atlanta, GA 07 APR 13 and 08 APR 13 The UPC code is (0)7653905520(0) Class I Product contains undeclared allergen, almonds. Naturally Fresh Inc.
Drugs Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-4699-24 07-893-DJ, exp. 7/2013, 10-123-DJ, 10-125-DJ, exp. 10/2013 Class II Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection. Hospira Inc.
Food Frozen tiny oyster meat I.Q.F. , 40x8oz (20lbs/case); Lot Number: Oyster Tiny: GL07240 Class II Interstate Seafood is recalling Korean Frozen Oysters because they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. Interstate Seafood Inc
Food Frozen Large Oyster meat I.Q.F, 6x5lbs.(20lbs) Lot Number:Oyster Large: GL07141; Class II Interstate Seafood is recalling Korean Frozen Oysters because they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. Interstate Seafood Inc
Food Frozen Half Shell Oyster meat I.Q.F, 5x4lbs (144pieces/case). Lot Number: Oyster Half Shell: GL06256. Class II Interstate Seafood is recalling Korean Frozen Oysters because they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. Interstate Seafood Inc
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