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U.S. Department of Health and Human Services

Enforcement Report - Week of September 30, 2015

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum. Model: TJF-Q180V, all sold units Class II New and validated reprocessing procedures have been issued for the Olympus TJF-Q180V duodenoscope ("TJF-Q180V"), consisting of revised manual cleaning and high level disinfection procedures. Olympus America Inc.
Veterinary CORID (amprolium) 9.6% Oral Solution Coccidiostat packaged in 16 oz plastic bottle, 12 bottles per case. NADA 013-149. OTC. UPC 3 50604 66970 8. Distributed by: Merial Limited, Duluth, GA. Lot HSH066, expiration date: 10DEC2019 Class III Product container does not conform to approved application. Huvepharma Inc
Devices Fujinon/Fujifilm Processor EPX 2500 Operation Manual. Part Numbers: 202B1230408A, 202B1230408B, 202B1230408C, 202B1230408D and 202B1230408E Class II Fujifilm Medical Systems, USA, Inc. (FMSU-ESD) has become aware that the EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be used with the EPX-2500 Processor. The Operation Manual and sales brochure state that when the ED-530XT endoscope is used with the 2500 processor, a "super image" is displayed when it is actually a "standard image" that is displayed. Fujifilm Medical Systems U.S.A., Inc.
Devices Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). Use to observe, record and capture images. 2500.0312.00 and 2500.0312.01 Class II Fujifilm Medical Systems, USA, Inc. (FMSU-ESD) has become aware that the EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be used with the EPX-2500 Processor. The Operation Manual and sales brochure state that when the ED-530XT endoscope is used with the 2500 processor, a "super image" is displayed when it is actually a "standard image" that is displayed. Fujifilm Medical Systems U.S.A., Inc.
Devices Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I. Hip implant component. Lot Code 3Y0KHP Class II it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. However the parts were inadvertently shipped to the field. Stryker Howmedica Osteonics Corp.
Devices Marketing brochures for the PowerPICC and PowerPICC SOLO catheters The brochures were purchased from the vendor on 04/14/2015, Code S120667R0 Class II Bard Access Systems is recalling marketing brochures for the PowerPICC® and PowerPICC® SOLO® catheters due to incorrect indication for use contained in the brochure. Bard Access Systems
Devices MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 10714149, 10714150. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST). Version 1.0 to Version 4.11 Class II Beckman Coulter is recalling the MicroScan LabPro Information Manager System because the software incorrectly allows the operator to manually edit the carbohydrate substrates when manually reading dried overnight gram negative panels with an ID Hold status. Beckman Coulter Inc.
Devices Lightspeed 16 CT 00000058433HM4 4860LS16GS FMI25463004 910213080 FMI25463005 910212101 FMI25463006 910212105 FMI25463007 910213064 FMI25463008 910216041 FMI25463009 910216036 00000321402CN0 910212106 00000325191CN5 AH5362CT02 FMI25463010 190020CT03 FMI25463011 110807CT01 00000980106YM9 110040CT03 00000307018CN2 416249LS16 00000298660CN2 204787LSPD2 00000318927CN1 514468BLS 00000329994CN8 819561LS 00000389961CN4 709891CT 00000335314CN1 514934CLS16 00000340630CN3 82421140148 00000331165CN1 82421010103 00000336002CN1 82421130067 00000334898CN4 82421140150 00000322331CN0 82421160145 00000999187YM8 82421100291 FMI25463133 828210047  ...
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Class II Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner. GE Healthcare
Devices PET Discovery LS 00000336259CN7 82445150008 00000357522CN2 RADNETPT608 00000316259CN1 210351MSDLS 00000293036CN0 352597PET 00000843236YM1 607766DLSPET 00000003458PT7 337407DLS Class II Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner. GE Healthcare
Devices PET Discovery ST 16 00000407058CN7 B5127901 00000393804CN0 YE0524 00000007118PT3 A098PE01 00000005880PT0 853450026 00000295121CN8 469525DLS 00000331760CN9 256327PET 00000305946CN6 201599DST 00000314955CN6 RADNETPT1813 00000362166CN1 203694DST16 00000354677CN7 918744PETCT 00000359856CN2 713704DST 00000364001CN8 845454PCT 00000299430CN9 817927DST 00000011079PT1 662232DST 00000005835PT4 256705PS2 00000010481PT0 615320DST 00000005903PT0 856794DISCST 00000412917CN7 818DCCDST Class II Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner. GE Healthcare
Drugs PHENYLephrine HCl, 50 mg added to 250 mL 0.9% Sodium Chloride Injection USP (200 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-171-50 Lot #: 14310039S, Exp 11/06/15; 14318006S, Exp 11/17/14; 14321060S, Exp11/07/15 Class I Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair). Pharmedium Services, LLC
Drugs PHENYLephrine HCl, 40 mg added to 250 mL 0.9% Sodium Chloride Injection USP (160 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-169-50 Lot #: 14309095S, Exp 02/03/15; 14311008S, Exp 02/05/15 Class I Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair). Pharmedium Services, LLC
Drugs Bupivacaine HCl 0.0625%, 250 mL total volume in a 250 mL LifeCare Bag in Sodium chloride 0.9%, Epidural Use Only, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-197-50 Lot #: 143140080M, Exp 02/09/15; 143210133M, Exp 02/16/15; 143490031M, Exp 03/16/15 Class I Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair). Pharmedium Services, LLC
Drugs Morphine Sulfate, 1 mg per mL (250 mg per 250 mL), 250 mL total volume in a 250 mL LifeCare bag in Sodium Chloride 0.9%, IV Use Only, Rx only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-181-50 Lot #: 14308162M, Exp 02/02/15; 143130049M, Exp 02/08/15; 143220039M, Exp 02/16/15; 143490058M, Exp 03/16/15; 143560029M, Exp 03/23/15 Class I Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair). Pharmedium Services, LLC
Drugs Fentanyl Citrate, 5 mcg per mL (1,250 mcg per 250 mL), 250 mL total volume in a 250 mL LifeCare bag in Sodium Chloride 0.9%, IV Use Only, Rx only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-107-50 Lot #: 14303122M, Exp 01/28/15; 14309029M, Exp 02/02/15; 14315067M, Exp 02/09/15; 14317040M, Exp 02/11/15; 14318026M, Exp 02/12/15; 14323089M, Exp 02/17/15; 14325128M, 14325124M, Exp 02/19/15 Class I Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair). Pharmedium Services, LLC
Drugs PHENYLephrine HCl, 20 mg added to 250 mL 0.9% Sodium Chloride Injection USP (80 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-156-50 Lot #: 14310063S, Exp 02/04/15; 14316086S, Exp 02/10/15; 14322138S, Exp 02/16/15 Class I Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair). Pharmedium Services, LLC
Drugs PHENYLephrine HCl, 60 mg added to 250 mL 0.9% Sodium Chloride Injection USP (240 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-236-50 Lot #: 14317035S, Exp 02/11/15 Class I Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair). Pharmedium Services, LLC
Drugs PHENYLephrine HCl, 10 mg added to 250 mL 0.9% Sodium Chloride Injection USP (40 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-149-50 Lot #: 14308086S, Exp 02/02/15; 14309051S, Exp 02/03/15 Class I Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair). Pharmedium Services, LLC
Devices ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer 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. PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer. Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording. ARTISTE - 08139789 ONCOR Avantgarde - 05863472 ONCOR Impression Plus - 05857912 ONCOR Expression  07360717 PRIMUS - K993425 PRIMUS Plus  04504200 Syngo RT Therapist - 08162815 serial numbers: 5177 3761 3981 3998 5096 70-4161 3354 10570 10793 10794 10796 10795 10798 10814 10792 5300 10046 10549 10687 3624 5350 5784 10586 5830 10010 5419 Class II A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients. Siemens Medical Solutions USA, Inc
Food Label reads in part as: "GRAVIOLA EXTRACT***1 FL Oz (30 ml)*** ORIGINAL FORMULA***Manufactured by: Majopa Industries Corp.*** PRODUCT OF PUERTO RICO,USA". Drug claims in the product label are as follows: "Researchers have found that Extracts from Graviola leaves can produce acetogenins which are extremely effective in the treatment of cancer cells. Graviola extract can works like an antibiotic against cancer cells by stopping growth of the enzymes needed for cell growth. It can be:cellular protector, anti tumorous, antiviral. Also can be used as: Digestive stimulant, Strengthens immune system, antifungal, tranquilizer". 02/2020 Class I Firm's dietary supplements were being promoted for conditions that caused the products to be drugs under the FD&C Act. Majopa Industries Corporation
Devices The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The Leica ASP6025 Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration. Product Code: Leica ASP6025 Serial Numbers: 163, 169, 200-729, 731, 733, 735, 737, 739, 741, 743, 745, 747, 749, 751, 753, 755, 757, 759, 761, 763, 765, 767, 769, 771, 773, 775, 777, 779, 781, 783, 785, 787, 789, 791, 793, 795, 797, 799, 801, 803, 805, 807, 809, 811. Class II The ASP6025 Tissue Processor instrument is incorrectly getting into a state of bottle empty during retort filling, after passing the fill lever sensor 2 and prior to reaching level sensor 3, thus not completing a 5 litre fill. Leica Microsystems, Inc.
Biologics Red Blood Cells Leukocytes Reduced W205513059778; Class II Misbranded Red Blood Cells were distributed. American National Red Cross, Greater Ozark-Arkansas Region
Devices 3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric orthopedics. Part number 00-0903-2510, Lot number 150192-J Class II The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a different screw. The screw in the package is a 00-0903-2526, 3.5mm x 26mm, and is etched correctly. OrthoPediatrics Corp
Devices ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box which is subsequently sterilized by gamma irradiation (ORS-2200 only) or ethylene oxide. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required. 02, D121852, D122162, D122222, D122362, D122522, D122552, D122932, D123472, D130022, D130173, D130233, D130313, D130393, D130433, D130493, D130583, D130653, D130743, D130813, D130863, D130933, D131003, D131063, D131123, D131213, D131363, D131423, D131473, D131553, D131623, D131703, D131793, D131853, D132043, D132103, D132173, D132331, D132451, D132521, D132591, D132661, D132801, D132841, D132941, D133051, D133151, D133191, D133291, D133401, D133431, D133471, D140201, D140341, D140441, D140511, D140651, D140931,  ...
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Class II This recall is being conducted because the sterile packaging may contain small (less than 250 microns wide) channels in the seal of the pouch. If channels are present, the package integrity is compromised and there exists a remote chance that a non-sterile drape may be used during a surgical procedure. Ecolab Inc
Devices Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions. Part Numbers 09.213.022S 09.213.024S 09.213.026S 09.213.028S 09.213.030S 09.213.032S 09.213.034S 09.213.036S 09.213.038S 09.213.040S 09.213.042S 09.213.044S 09.213.046S 09.213.048S 09.213.050S 09.213.052S 09.213.054S 09.213.056S 09.213.058S 09.213.060S 09.213.065S 09.213.070S 09.223.032S 09.223.034S 09.223.036S 09.223.038S 09.223.040S 09.223.042S 09.223.044S 09.223.046S 09.223.048S 09.223.050S 09.223.055S 09.223.060S 09.223.065S 09.223.070S 09.223.075S 09.223.080S 09.223.085S 09.223.090S with Lot Numbers 2799588 2799590 2801042 2801043 2802483  ...
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Class II DLS pin breakage during planned implant removal, after uneventful and successful healing of the fracture. This notice to additional consignees identified after recall Z-0390-2014, related to complaints of breakage located at the bottom of the screws and under the locking screw head. Synthes (USA) Products LLC
Devices Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system. They are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field. Radiology. Model numbers: 41773G Disposable Reflective Marker Sphere (90 Pcs.) 41774G Disposable Reflective Marker Sphere (270 Pcs.) 41772G Disposable Reflective Marker Sphere (3 Pcs) Catalogue numbers: 41773G Disposable Reflective Marker Sphere (90 Pcs.) 41774G Disposable Reflective Marker Sphere (270 Pcs.) (Note: 41772G is not available as single item for sale, but contained in the above 41773G or  ...
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Class II Disposable Reflective Marker Spheres (DRMS) for Brainlab Image Guided Surgery (IGS) Systems: DRMS spheres may separate at the mid-point where the two halves of the sphere are sealed together. Brainlab AG
Devices Regard (tm), Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures. 023735 Class II Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance. Resource Optimization & Innovation Llc
Devices Regard (tm), Item Number: 800208002; Sterile, CV0361B - CABG A&B. Used in cardiovascular surgical procedures. 025072B Class II Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance. Resource Optimization & Innovation Llc
Devices Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed. Lot Number: TE06 Class II Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators Terumo Cardiovascular Systems Corp
Devices Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak P/N: 73124 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed Lot Numbers: TD02,TD02A, TD23, TD23A Class II Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators Terumo Cardiovascular Systems Corp
Devices Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE P/N: 7928-03 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed Lot Numbers: TD02, TD16 Class II Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators Terumo Cardiovascular Systems Corp
Devices Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74039-02 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed Lot Numbers: TD02 Class II Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators Terumo Cardiovascular Systems Corp
Devices Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74077-01 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed Lot Numbers: TD23 Class II Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators Terumo Cardiovascular Systems Corp
Devices Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75185 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed Lot Number: TD02 Class II Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators Terumo Cardiovascular Systems Corp
Devices Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed Lot Number: TC23 Class II Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators Terumo Cardiovascular Systems Corp
Drugs Refresh Lacri-Lube (Mineral Oil 42.5% and White Petrolatum 56.8%) Lubricant Eye Ointment, packaged in a) Net wt. 0.12 oz (3.5 g) tubes (NDC 0023-0312-04) UPC 3 0023-0312-04 2 and b) Net wt. 0.25 oz (7 g) tubes (NDC 0023-0312-07) UPC 3 0023-0312-07 3, Allergan, Inc., 2525 Dupont Drive, Irvine, CA 92612. Lot #: a) 84746, Exp 04/17; 84987, 85087, Exp 05/17; 85359, Exp 06/17; 85721, Exp 07/17; 86045, Exp 08/17; 86406, Exp 09/17; 86594, Exp 10/17; 87021, Exp 11/17; and b) 86470, Exp 09/17; 86829, Exp 10/17; 87105, Exp 11/17 Class II Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product. Allergan Sales, LLC
Drugs Refresh P.M. (Mineral Oil 42.5% and White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt. 0.12 oz (3.5 g) tube, Allergan, Inc., 2525 Dupont Drive, Irvine, CA 92612, NDC 0023-0240-04, UPC 3 00230 66704 3. Lot #: 85165, 85228, Exp 05/17; 85244, 85351, 85374, 85397, Exp 06/17; 85561, 85676, 85694, Exp 07/17; 85834, 85977, 85985, 86073, Exp 08/17; 85599, 86290, 86325, 86411, 86427, 86506, 86515, 86517, Exp 09/17; 86746, 86792, 86789, 86809, 86822, 86822A, Exp 10/17; 86932, 87100, 87068, Exp 11/17; 87156, 87261, Exp 12/17;  ...
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Class II Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product. Allergan Sales, LLC
Drugs FML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g tube, Rx only, Allergan, Inc., Irvine, CA 92612, NDC 0023-0316-04, UPC 3 0023-0316-04 0. Lot #: 86258, Exp 09/16; 87189, Exp 12/16; 87514, Exp 02/17 Class II Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product. Allergan Sales, LLC
Drugs BLEPHAMIDE (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10 %/0.2 %, 3.5 g tube, Rx only, ALLERGAN, Irvine, California 92612, NDC 0023-0313-04, UPC 3 00230 31304 9. Lot #: 86430, Exp 09/17; 87806, Exp 02/18; 88147, Exp 03/18 Class II Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product. Allergan Sales, LLC
Devices PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-M-11P, PB-M-15 Product Code PB-M-10, Lots 140901J-A, 150228PB10, 150509PB10, 150510PB10; Product Code PB-M-11P, Lots 140901J-B, 150227PB11, 150318PB11, 150509PB11, 150510PB11; Product Code PB-M-15, Lots 140901J-C, 150226PB15, 150326PB15, 150511PB15, 150512PB15, 150529PB15. Class II Cracks were discovered in the PET tray of a small population of sterile product. These cracks create a risk of loss of sterile barrier for the product. Sampling and root cause analysis indicated that the risk could extend throughout the lots manufactured from September 2014-July 2015. This led to the decision to recall the product. Zien Medical Technologies, Inc
Food FRESH ORIGINS Microgreens Celery NET WT 4 OZ San Marcos, CA 92069 packed in clear plastic clam shell. 1899 Class I Tested positive for Salmonella Hardies Fruit & Vegetable Co., LP
Devices Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number: 10491449 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCHb, FMetHb, FHHb, nBili Serial Numbers: 2517102517 through 2519000012. Cartridges within this serial number range that have a green dot on the box and/or the cartridge are not affected Class II RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results Siemens Healthcare Diagnostics Inc
Devices Siemens RAPIDPoint 500 Measurement Cartridge Lactate (400) tests Part Number: 10491448 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCHb, FMetHb, FHHb, nBili Serial Numbers: 2517102517 through 2519000012. Cartridges within this serial number range that have a green dot on the box and/or the cartridge are not affected Class II RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results Siemens Healthcare Diagnostics Inc
Devices Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests Part Number: 10491447 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCHb, FMetHb, FHHb, nBili Serial Numbers: 2517102517 through 2519000012. Cartridges within this serial number range that have a green dot on the box and/or the cartridge are not affected Class II RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results Siemens Healthcare Diagnostics Inc
Devices Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number: 10844813 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCHb, FMetHb, FHHb, nBili Serial Numbers: 2517102517 through 2519000012. Cartridges within this serial number range that have a green dot on the box and/or the cartridge are not affected Class II RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results Siemens Healthcare Diagnostics Inc
Devices ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement Pack (Model VPP). packaged sterile and non-pyrogenic in a sealed, peel-type pouch. The Knot Pusher is a sterile disposable plastic rod used to advance extracorporeal suture knots during minimally invasive cardiac surgery. Model: KP1 - Lot No: 59964698, 59967596, 59984375, 60016312, 60045801, 60045802, 60059982, 60066591, 60089865 Model VPP Lot No: 60022521, 60022522, 60064112 Class II Edwards Lifesciences is recalling certain lots of ThruPort Systems Knot Pusher (Model KP1) and ThruPort Systems Valve Placement Pack (Model VPP) because the configuration of the slot at the tip of the knot pusher may inhibit intended ease of use. Fraying or splitting of the suture could occur, which could compromise the integrity of the suture knot. Edwards Lifesciences, LLC
Food Sam Mills Gluten Free Chocolate Chip Granola Bars with Dark Chocolate 5 bars/4.4oz Box (0.88oz each bar) Lot code: 10202014 exp. date 10/20/2015, Lot code: 11202014 exp. date 11/20/2015, Lot code: 12082014 exp. date 12/08/2015 (two shipments of this lot/exp on one day), Lot code: 02172015 exp. date 02/17/2016, Lot code: 02122015 exp. date 02/12/2016, Lot code: 02252015 exp. date 02/25/2016, Lot code: 02132015 exp. date 02/13/2016, Lot code: 02122015 exp. date 02/12/2016, Lot code:  ...
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Class I Undeclared milk Sam MillsUSA LLC
Food Smoked Tofu is tofu sandwich on bread or a bun, enclosed in a clam shell with label 08 30 (Use By August 30th) 09 02 (Use By Sept. 2nd) Class II Product contains wheat bun but the ingredients statement does NOT declare wheat and the Contains statement declared Soy only. Hillside Quickie Too
Food New York Deli Tofu is is tofu sandwich on bread or a bun, enclosed in a clam shell with label 08 30 (Use By August 30th) 09 02 (Use By Sept. 2nd) Class II Product contains wheat bun but the ingredients statement does NOT declare wheat and the Contains statement declared Soy only. Hillside Quickie Too
Food Jamaica Spice Tofu is Tofu sandwich on bread or a bun, enclosed in a clam shell with label 08 30 (Use By August 30th) 09 02 (Use By Sept. 2nd) Class II Wheat bun is declared in the Ingredients statement but the Contains statement declared Soy only. Hillside Quickie Too
Food Jamaican Spice Tempeh is tofu sandwich on bread or a bun, enclosed in a clam shell with label 08 30 (Use By August 30th) 09 02 (Use By Sept. 2nd) Class II Wheat bun is declared in the Ingredients statement but the Contains statement declared Soy only. Hillside Quickie Too
Food Seitan Steak is tofu sandwich on bread or a bun, enclosed in a clam shell with label 08 30 (Use By August 30th) 09 02 (Use By Sept. 2nd) Class II Wheat bun is declared in the Ingredients statement but the Contains statement declared Soy only. Hillside Quickie Too
Food Tofustrami is tofu sandwich on bread or a bun, enclosed in a clam shell with label 08 30 (Use By August 30th) 09 02 (Use By Sept. 2nd) Class II Wheat bun is declared in the Ingredients statement but the Contains statement declared Soy only. Hillside Quickie Too
Drugs 0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38 Lot #: P329821, Exp 08/31/2016 Class II Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch. Baxter Healthcare Corporation
Devices CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in Hematology: The SK3 monoclonal antibody reacts with human CD4, a 59-kDa cell surface receptor expressed by a majority of thymocytes, a subpopulation of mature T helper cells, and at low levels on monocytes. CD4 is a receptor for the human immunodeficiency virus (HIV). Catalog Number 340133; lot # 5112711, Expiration date: 30 Nov 2016. Class III CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC. Becton, Dickinson and Company, BD Biosciences
Drugs 1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose Preservative Free, Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-4279-02 Lot #: 44-359-DK, Exp 08/01/2016 Class II Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials. Hospira, Inc.
Devices Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures Catalog numbers: 1600939-001 and 1600938-001 Serial numbers concerned: - Ref: 1600939-001: Serial numbers included in the following range: 15B0001 up to 15F0011 - Ref: 1600938-001: Serial numbers included in the following range: 15B0007 up to 15F0027 Class II Bien-Air Dental SA is recalling Contra-Angles CA1:1L EVO 15 because of possible loosening of the dental tool, which may lead to potential swallowing of it. Bien Air Dental SA
Devices Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. Part Number 329.315 460.001 460.001.01S 460.002 460.002.01S 460.003 460.003.01S 460.008 460.008.01S 460.009 460.009.01S 460.010 460.010.01S 460.100 460.100.01S 460.107 460.107.01S with Lot Numbers 4146716, 4154144, 4206682, 4206683, 4213557, 4214824, 4216603, 4216604, 4240689, 4240690, 4241741, 4248462, 4249395, 4249396, 4264386, 4278302, 4278304, 4283035, 4283036, 4283037, 4283038, 4283039, 4283040, 4283041, 4285956, 4289103, 4295084, 4295085, 4298044, 4303093, 4326975, 4326979, 4326981, 4329355, 4331263, 4331265, 4331266, 4344659, 4344678, 4378973, 4482201, 4485317, 4488093, 4488094, 4490608, 4490609, 4496716,  ...
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Class II The Synthes Cranial Flap Tube Clamp and Crimping Device for Cranial Tube Clamp had been labeled MR Safe although they do not have the testing protocols currently required to designate them as MR Safe. Synthes (USA) Products LLC
Biologics Red Blood Cells Leukocytes Reduced W270115213177; Class II Blood products, collected from an ineligible donor, were distributed. Central Pennsylvania Blood Bank
Biologics Platelets Pooled Leukocytes Reduced W270115519580; Class II Blood products, collected from an ineligible donor, were distributed. Central Pennsylvania Blood Bank
Biologics Cryoprecipitated AHF W200414044176002, W20041406179100E, W20041406179900Z, W200414101511005 Class II Blood Products, lacking assurance of collection in an aseptic manner, were distributed. Arc Blood Services, New England Region
Biologics Plasma Cryoprecipitate Reduced W20041409813600G Class II Blood Products, lacking assurance of collection in an aseptic manner, were distributed. Arc Blood Services, New England Region
Biologics Plasma Frozen within 24 Hours After Phlebotomy W20041406169500E, W20041406170100D, W20041406286800P, W200414062909002, W200414067327003, W20041407057100M, W20041409662500E, W20041409811500Q, W20041409812700I, W20041409819800P, W200414101184003 Class II Blood Products, lacking assurance of collection in an aseptic manner, were distributed. Arc Blood Services, New England Region
Biologics Red Blood Cells, Leukocytes Reduced W20041406242000F, W20041406243700Y, W200414062441005, W20041407395400I, W20041407395800A, W20041407834700L, W20041407835600J, W20041408119600P, W200414081235006, W200414081237002, W200414081243006, W200414081244004, W20041408161400L, W20041409388300Q, W20041409389700E, W20041409580400O, W20041409580800G, W20041409581900A, W20041409582500E, W20041409585700Z, W200414095860008, W200414095864000, W200414095871002, W20041409661700E, W20041409662500E, W20041409666800T, W20041409668200X, W200414097540008, W20041409754600X, W20041409755500V, W20041409811500Q, W20041409811800K, W20041409812700I, W20041409814400G, W20041409815300E, W20041409819300Z, W20041409819600T, W20041409819800P, W20041409820100U, W20041409820500M, W20041409820700I, W200414100463005, W20041410048300Y, W20041410080400W, W20041410081400S, W20041410082000W, W200414101165009, W200414101175005, W200414101184003, W20041410119800S,  ...
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Class II Blood Products, lacking assurance of collection in an aseptic manner, were distributed. Arc Blood Services, New England Region
Biologics Cryoprecipitated AHF, Pooled W20041490306500S, W20041490322200Y, W20041490323000Y, W20041490324100S, W20041490332000U, W200414903339008, W200414903381004, W20041490339900L, W20041490340300O, W200414903630002, W200414903687005, W200414903872003, W20041490390500H, W200414903929001, W20041490394000B, W200414903942007, W200414903951005, W20041490396400W, W20041490398700I, W20041490402200Y, W20041490404400M, W20041490405000Q, W200414904083008, W20041490416000E, W20041490423100G, W20041490429500L, W20041490435500T, W20041490436000Z, W200414904407000, W20041490442600V, W20041490443200Z, W20041490445000V, W20041490445600J, W200414904469009, W200414904485009, W200414904488003, W200414905390007, W200414905391005, W20041490545100D, W200414906004006, W200414906007000, W20041490601000A, W20041490613200R, W200414906176003, W20041490617800, W200414906272003, W20041490627500Y, W20041490627700U Class II Blood Products, lacking assurance of collection in an aseptic manner, were distributed. Arc Blood Services, New England Region
Biologics Red Blood Cells Leukocytes Reduced Irradiated W20041404469400W, Class II Blood Products, lacking assurance of collection in an aseptic manner, were distributed. Arc Blood Services, New England Region
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