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U.S. Department of Health and Human Services

Enforcement Report - Week of May 21, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Food Kaija Ivasi Lightly Salted Herring Fillets in Oil UPC 3585600709 UPC 3585600709 September 7 2013 Class II Kaija Ivasi lightly salted herring does not meet water phase salt standard of five percent for processed fish. Zip International Group LLC.
Food GOOD TASTE brand Plum, 10.5 OZ, PRODUCT OF CHINA, UPC 3 867320 507650 --- AMERICA MANDY STAR TRADING 2013.01.18 Class I The product contained undeclared sulfites (440 ppm), undeclared FD&C Yellow # 6, and unapproved color Ponceau 4R, based on sampling and analysis by New York State Department of Agriculture & Markets. Mandy Star Trading Inc
Devices Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap; Product number DYND44140 (pack of 50), Product number DYND44140H (individual). Mucus Specimen Trap 80 cc, Specimen Trap 80 cc w/ additional transport cap; Product number DYND44180 (pack of 50). Used to collect mucus specimens during suction of fluid from the oral cavity, nose-throat area and/or bronchi of a patient. Model Numbers: DYND44140, DYND44140H, and DYND44180; Purchase Order Number: 4506595929 Class II There is a potential that the specified mucus specimen traps are not sterile. Use of the affected products may result in the contamination of patient specimens. Medline Industries Inc
Devices HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage ventricular heart failure.The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter. Catalog# USA:1650 // OUS: 1650, 1650-DE All HeartWare Battery Serial Numbers Class II Patients and caregivers are instructed that if a battery does not provide two hours of support or behaves unusually, that battery should no longer be used and should be replaced. HeartWare Inc
Drugs REUMOFAN PLUS Tablets, 30 Tablet Bottles, OTC. Previene el cancer en los huesos, Nueva presentacion el original. All lots Class I Marketed Without an Approved NDA/ANDA; Product contains undeclared diclofenac and methocarbamol. Pain Free By Nature
Food Adult Herbal Blend 992 Item #H039 30 KGS PO#33590 Raw Deal Inc. PO Box 412 Allamuchy, NJ 07820 Phone: 973-347-6400 Fax: 973-347-5999 www.raw-deal.net Batch @992-20131107-00-02 Class I Raw Deal is recalling dietary blends which may contain salmonella. RAW DEAL
Food Cilantro Powder Item #13151 22.5 KGS PO #P41049 Raw Deal Inc. PO Box 412 Allamuchy, NJ 07820 Phone: 973-347-6400 Fax: 973-347-5999 www.raw-deal.net Batch #CP-20131024-00178 Class I Raw Deal is recalling dietary blends which may contain salmonella. RAW DEAL
Food Parsley Powder Organic 25 KGS PO# GV93-6 & PO#RV19-4 Raw Deal Inc. PO Box 412 Allamuchy, NJ 07820 Phone: 973-347-6400 Fax: 973-347-5999 www.raw-deal.net Batch #PPO-20131113-15-178 and Batch #PPO-20131003-00-01 Class I Raw Deal is recalling dietary blends which may contain salmonella. RAW DEAL
Drugs GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC: 0093-5712-05 TE36018, Exp. 06/15 Class II CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements Teva Pharmaceuticals USA
Drugs INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4029-01 TE32134, Exp. 02/15 Class II CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements Teva Pharmaceuticals USA
Drugs INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 TE38139, Exp. 08/16, TE39022, Exp. 09/16, Class II CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements. Teva Pharmaceuticals USA
Drugs METHYLDOPA Tablets USP, 500 mg, 100 count bottle, Rx only, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-2932-01 TE36053A,TE36063A, Exp. 06/16 Class II CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements Teva Pharmaceuticals USA
Drugs Smart Tab First Aid ezRefill System Ibuprofen dispenser boxes (Item Number FAE 7014), 20 count boxes, First Aid Only Inc., Vancouver, WA Aspirin was packed into Ibuprofen boxes (Item Number FAE-7014) coded: B11340515, B11840515, B12040615, B12540615, B12640615, B12740615, C10340615 and B11040516. Class II First Aid Only, Inc is recalling Smart Tab First Aid ezRefill System Ibuprofen boxes and First Aid Cabinets containing these Ibuprofen boxes. Ibuprofen boxes (FAE 7014) were accidentally used to package aspirin packs (10 packs of 2 / 235mg tablets). First Aid Only Inc
Food Fresh Express, Italian, Crunchy Romaine Lettuce and Red Cabbage Salad, 10oz clear plastic bags, UPC: 71279-21100. Product Code: H071A11A, Best buy date: 26-Mar Class I Product was found to be contaminated with Listeria monocytogenes Chiquita Brands International, Inc.
Food Deb-El Foods Dried Whole Eggs Deb El Food Products LLC 2 Papetti Plaza, Elizabeth, NJ 07206 2053, 2353, 3173, 3193, 3243, 2343, 3313, 3463, 0863 Class I Deb-El Food Products LLC is recalling dried whole eggs due to undeclared milk. Deb-El Food Products, LLC.
Devices ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition), 8300-0156 ABACUS 3.0 CE, 8300-0157 ABACUS 3.0 SE, 8300-0158 ABACUS 3.0 ME, 8300-0166 ABACUS 3.1 DE, 8300-0167 ABACUS 3.1 CE, 8300-0168 ABACUS 3.1 SE, 8300-0169 ABACUS 3.1 ME. ABACUS is a Windows - based order entry TPN software application for comprehensive calculations and label printing. The primary use of Abacus is for Total Parenteral Nutrition (TPN) order calculations. Product Code 8300-0045, 8300-0046, 8300-0047, 8300-0156, 8300-0157, 8300-0158, 8300-0166, 8300-0167, 8300-0168, 8300-0169 Class I 1. ABACUS v3.1 may calculate quantities of electrolytes that are double the expected values during the creation of TPN orders. 2. ABACUS v3.1 may automatically add additional sterile water to a formula equal to the volume of a premix resulting in an over dilution. 3. All software versions of ABACUS software display the calcium phosphate curve points for Premasol incorrectly. 4. All software versions of ABACUS may display an inaccurate estimation for calcium/phosphate precipitation in certain circumstances where multiple ingredients provide calcium. Baxter Corporation Englewood
Devices MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Serial Numbers: NNBLTL, NNBLT5, NNBLR9, NNBLT2, NNBLJP, NNBLL2, NNBLJR, NNBLLH, NNBLLJ, NNBLLG, NNBLT0, NNBLT1, NNBLL7, NNBLTC, NNBLTN, NNBLTK, NPBLZ7, NPBLZH, NPBLZP, NPBLZN, NPBLZM, NPBLZK, NPBLZ4, NPBLZJ, NPBLY3, NPBLY5, NPBLY4, NPBLY7, NPBLZT, NPBLY9, NPBLZR, NPBL7M, NPBL74, NPBMFN, NPBMF0, NPBMHJ, NPBMHK, NPBL71 NPBL9H, NNBLLP, NNBLLN, NNBLLC, NNBLLD, NNBLL3, NPBL0F, NNBLTH, NPBL6N, NPBL6M, NPBL6L,  ...
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Class II A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life. Codman & Shurtleff, Inc.
Devices MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Serial Numbers: NNBLV3, NNBLHF, NNBLK4, NNBLV4, NNBLV6, NPBL9F, NPBL89, NPBL8R, NPBL8T, NPBL9B, NPBL77, NPBL2K, NPBL8V, NPBL9D, NPBL8C, NNBLHH, NNBLHD, NNBLHB, NNBLHJ, NNBLHC, NNBLHG, NNBLV7, NNBLV5, NNBLV0, NNBLWC, NPBL2G, NPBL1F, NPBL1D, NPBL1B, NPBL09, NPBL88, NPBL7R, NPBL2N, NPBL6Z Class II A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life. Codman & Shurtleff, Inc.
Devices DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG, arrhythmia detection, ST segment analysis, heart rate (HR), respiration rate (RESP), temperature, pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM) monitor p/n 6802F-PA00001 module p/n 115-001704-00/M51A-30-80876 Class II The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing. Mindray DS USA, Inc. dba Mindray North America
Food TRADER GIOTTO'S CAESAR SALAD with Caesar Dressing, NET WT. 8/5 OZ (241g). Sell by 4/6/14, 4/7/14, and 4/8/14. Class I Product labeling on Trader Giotto's Caesar Salad with Caesar Dressing may not list wheat, soy, egg and fish (anchovy) allergens. H Group
Food Soy Bean Cake Net Wt. 9. oz. Ingredient: Soybeans, water, salt, Soy sauce, Spice, Calcium Sulfate. Perishable, keep refrigerated. Fong Kee Tofu Inc. 1135 Revere Ave. San Francisco, CA 94124. No codes Class II Soy Bean Cake products do not declare wheat, a sub ingredient of soy sauce. Fong Kee Tofu Co., Inc.
Devices Syngo Dynamics Product Usage: Syngo Dynamics is a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used for reading of mammography images. model numbers: 10091805, 10091806, 10091807, 10091673 with serial numbers: 85170 85250 85188 85191 85198 85151 85165 85241 85130 85163 85019 85287 85298 85202 85168 85068 85206 85280 85235 85195 85194 85123 85199 85364 85282 85275 85115 85062 85067 85080 85216 85218 85177 85242 85248 85237 85284 85329 85259 85279 85230 85192 85277 85278 85178 85220 85157 85114 85268 85134 Class II Siemens Medical Solutions USA, Inc. has become aware of a potential issue with the Syngo Dynamics v9.5 system with a specific set of serial numbers. Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display. Siemens Medical Solutions USA, Inc
Devices ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip 51 count retail strip; 102 count retail strip; 51 count MedBen strip 51 count Mail Order strip; Sample Kit 16 per case. The ACCU-CHEK Compact Plus Test Strips are for use with the ACCU-CHEK Compact Plus Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm. 5599423160, 5599415160, 5919967160, 5919959160, 5919983160, 5907675001 Class II Roche Diabetes Care has become aware the ACCU-CHEK Compact Plus test strips may produce erroneously low blood glucose readings in patients undergoing Ceftriaxone therapy. The interference is not described in the product labeling. Roche Diagnostics Operations, Inc.
Devices InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty. Lot numbers: 101637, 101640 Class II InterValve V8 Transluminal Balloon Aortic Valvuloplasty Catheter Devices were retrieved after leak issues were discovered through accelerated age testing. InterValve Inc
Food Swanson Full Spectrum Cilantro (Coriander) Herbal Supplement, 60 capsules, 425 mg, SW1112. UPC 87614-11112 Lot 203921 and 204888 each with MFG Date 11/2013 Class I The contract manufacturer has notified Swanson Health Products that Swanson Full Spectrum Cilantro (Coriander) (SW1112) is subject to a recall due to a potential risk of salmonella contamination. Swanson Health Products, Inc
Devices SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory information system to be used in medical results, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data processing and laboratory activities for microbiology and serology testing, for the purpose of storing, managing, querying, and reporting laboratory data. SA HIS version 4.0.7.0 Class II When an isolate is resulted without a SNOMED code, isolate information in the downstream system may be incomplete or missing. As a result, there is the potential for the delay or omission of patient treatment updates. SCC Soft Computer
Food Fernandez True Chile Flavor, Medium Hot Chile Molido Puro, 4 oz. UPC 77601-10011, Lot Code JAN-17 Class I Fernandez Chile Company is recalling 4oz Chile Molido Puro medium hot UPC 77601-10011 and 6oz Chile Rojo mild UPC 77601-10053 due to contamination with Salmonella. Fernandez Chile Company, Incorporated
Food Fernandez True Chile Flavor, Mild Chile Rojo, 6 oz. UPC 77601-10053, Lot FEB-17 Class I Fernandez Chile Company is recalling 4oz Chile Molido Puro medium hot UPC 77601-10011 and 6oz Chile Rojo mild UPC 77601-10053 due to contamination with Salmonella. Fernandez Chile Company, Incorporated
Devices NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020. SN000090, SN000091, SN000092, SN000187, SN000200, SN000204, SN000226, SN000231, SN000232, SN000246, SN000247 Class II Blue Belt Technologies is conducting a voluntary recall for their Navio PFS system which is used during orthopedic knee surgery. One of the electronic modules inside the computer cart assembly may have a defect in one of its components that could result in a latent failure. Blue Belt Technologies MN
Devices DROP LOK" Knee Brace***LATEX FREE" Product Usage: Used in the treatment, support, and rehabilitation of many types of knee injuries or following surgical correction. Model #: 00-1746-001-00 through 00-1746-006-00 Class II During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex. Zimmer, Inc.
Devices Cartilage Knee Brace***LATEX FREE" Product Usage: Used in the treatment and support of many types of knee injuries or following surgical and nonsurgical correction. Model #: 00-1747-001-00 through 00-1747-005-00 Class II During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex. Zimmer, Inc.
Devices Hinged Knee Support***LATEX FREE" Product Usage: Provide added lateral stability and allows the knee to tolerate more strenuous activity during recuperation. Model #: 00-1773-002-00 through 00-1773-008-00 Class II During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex. Zimmer, Inc.
Devices Tennis Elbow Support, Neoprene***LATEX FREE" Product Usage: Provides compression and warmth for mild to moderate elbow strains and sprains. Model #: 00-3448-003-00 through 00-3448-006-00 Class II During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex. Zimmer, Inc.
Devices Ultrasound needles, 22G (0.7 mm) x 50mm, packaged individually, 10 needles/box, item number REF USC050-22. Needles for peripheral nerve blocking under ultrasound guidance. Lot B3170005, EXP 2018-05-31 Class II Ultra sound needles may be defective and leak at the needle hub. RM Temena GmbH
Devices Ultrasound USB needles, with 30degree bevel, packaged individually, 10 needles/box, item number REF USB050-22. Needles for peripheral nerve blocking under ultrasound guidance Lot B3070012 EXP 2018-02-28 Lot B3250001 EXP 2018-06-30 Lot B3250026 EXP 2018-06-30 Class II Ultra sound needles may be defective and leak at the needle hub. RM Temena GmbH
Devices PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures. Lot No. A131876 Class II A femoral component containing pegs was found in a box for the pegless version. Ortho Development Corporation
Devices RAPIDFILL Syringe Strip, For use with RAPIDFILL Automated Syringe Filler (ASF): H93890200 RAPIDFILL Syringe Strip, White. H93890221 RAPIDFILL Syringe Strip, Yellow. H93890222 RAPIDFILL Syringe Strip, Orange. H93890223 RAPIDFILL Syringe Strip, Red. H93890225 RAPIDFILL Syringe Strip, Blue. H93890227 RAPIDFILL Syringe Strip, Salmon. H93890229 RAPIDFILL Syringe Strip, Violet. H93890231 RAPIDFILL Syringe Strip, Gray. H93890232 RAPIDFILL Syringe Strip, Green. Sterile 10 ml syringes with twist-off luer sealing tip caps banded together with label material. Product Code: H93890200 Lots 787032 to 790790; Codes H93890221 Lots 789096 to 791247; Code H93890222 Lots 787761 to 790791; Code H93890223 Lots 786926 to 789793; Code H93890225 Lots 789794 to 790792; Code H93890227 Lots 789098 to 791246; Code H93890229 Lots 789637 to 790794; Code H93890231 Lots 788465 to 790795; Code  ...
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Class II Baxter Corporation is recalling certain lots of RAPIDFILL Syringe Strip due to a possible breach in sterile barrier for inner and outer bags of the product. Baxter Corporation Englewood
Devices Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190713 Revision K Revision K Actuator Test Boards S/N of 2008 T Machines: 3T0S124903 3T0S124937 3T0S124933 3T0S124986 3T0S124934 3T0S124970 3T0S124894 3T0S124935 3T0S124912 3T0S124965 3T0S124944 3T0S124988 3T0S124939 3T0S124990 3T0S124940 3T0S124941 3T0S124958 3T0S124888 3T0S124946 3T0S124999 3T0S124942 3T0S124991 3T0S125023 3T0S124951 3T0S124936 3T0S124895 3T0S124955 3T0S125000 3T0S124943 3T0S125010 3T0S124893 3T0S124954 3T0S124896 3T0S124899 3T0S124959 3T0S125008 3T0S124947 3T0S125018 3T0S124905 3T0S124961 3T0S124898 3T0S124907 3T0S124963 3T0S124891 3T0S124952 3T0S125028 3T0S124920 3T0S124966 3T0S124910 3T0S124909 3T0S124967 3T0S124901 3T0S124953 3T0S125029 3T0S124922 3T0S124969 3T0S124913 3T0S124911 3T0S124972 3T0S124902 3T0S124960 3T0S124930 3T0S124925 3T0S125011 3T0S124921 3T0S124916 3T0S124979 3T0S124918 3T0S124962 3T0S124945 3T0S124926 3T0S125013 3T0S124927 3T0S124917 3T0S124984 3T0S124928 3T0S124968 3T0S124964 3T0S124932 Class II 2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump Fresenius Medical Care Holdings, Inc.
Devices Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190713 Revision K Revision K Actuator Test Boards Class II 2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump Fresenius Medical Care Holdings, Inc.
Food Hickory Farms Farmstand Recipe Chipotle Ranch Sauce Net Weight 9 Ounces Best if used by date of February 08, 2015 or earlier Class I product contains undeclared milk Hickory Farms Inc
Drugs PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC. Manufactured By: Konsyl Pharmaceuticals, Inc., Easton, MD 21601. NDC: 0224-1847-10. Lot #: A44701 (expiry: 07/16) , A44701C (expiry: 07/16), J34701C-1 (expiry: 07/16) Class III Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate. Konsyl Pharmaceuticals Inc
Food Frozen Corkscrew Pasta and Creamy tomato Vodka Sauce meal, Net Wt 9oz UPC Code: 2780607001, Date Code: 00914 and 01314. Class I Undeclared allergen: pinenuts. Dd Foodsolutions Inc.
Devices Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural. Serial no. 14031885 14031892 14031897 14031916 14032037 14032060 14032075 14032083 14032091 14032105 14032510 14032588 14032682 14032683 14032684 14032686 14032729 14032741 14032774 14032775 14035370 14035776 14035827 14035855 14035963 14036178 14036191 14036215 14036219 14036422 12773501 13184780 13932274 13932283 13932301 13932329 13932333 13990520 13990521 13990661 13990694 13990697 13990698 13990699 13990701 13990738 13990741 13990742  ...
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Class I CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software issue that results in situation where the pump module will not properly delay an infusion when the "Delay Until" option or "Multidose" feature is used. CareFusion 303, Inc.
Food 2372 HOT & SPICY; 4 pound plastic gallon containers; UPC 0 9093912372 7 Interal Lot # 14012515001 and UPC-A Code 0 90939 12372 7 Class III Cajun Savory was packed in Hot & Spicy package Gold Medal Products
Food Organic Basil 2.5 oz Lot codes: 2/21 20422 Class I FDA (CFSAN 3rd party sampling project) sample collected was found to be positive for Salmonella Infinite Herbs, LLC
Devices Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Intended to provide invasive or noninvasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. Part Number: SBC2105A. Model Number(s): e360 Ventilator. Serial numbers N11360719000 through N14360426029. Class II Newport Medical Instruments, Inc. is conducting a voluntary field corrective action on specific Newport" e360 ventilators with a particular single board computer (SBC), in response to customer reports of the audible alarm not sounding when the ventilator is in an alarm state. The ventilator, as well as the visual and remote alarms, continue to operate normally. Nellcor Puritan Bennett Inc. (dba Covidien LP)
Devices ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone, including the spine and cranium. Lot/Set/Serial: G323081803. Class II Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product. The Anspach Effort, Inc.
Food Hickory Farms Chipotle Ranch Sauce; 9 oz. clear plastic pinch waist bottle Best if used by date of February 08, 2015 or earlier Class I Unlabeled milk allergen. Woeber Mustard Manufacturing Co Inc
Devices Enaly 1000 BT-12 Ozone Generator, Model # 1000BT-12 The 1000BT-12 ozone generator is capable of delivering up to 1gram of ozone per hour from pure oxygen. The 1000BT-12 ozone generator is designed to continuously generate ozone by corona discharge. The conversion of oxygen to ozone occurs in a reaction cell excited by a high voltage potential. A control circuit allows the user to manually adjust the ozone output between 40-100% of its rated output. Lot # 10BT-091237 Class II William Domb is recalling the Enaly 1000 BT-12 Ozone Generator because it is not approved or cleared by the FDA for medical use. William C. Domb, D.M.D., A Professional Corporation
Devices ExploR 7x26mm Modular Radial Stem, Product Usage: Biomet manufactures a variety of elbow joint Radial Head and Modular Radial Head prostheses intended for primary and revision joint athroplasty for use in cemented and uncemented press fit applications. Page 5 of the surgical technique states Once the radial head has been fully seated on the radial stem, place the set screw packaged with the stem to secure the head to the stem. Catalog Number: 11-210062 Lot Number Identification: 972230 Class II This lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads. If the wedge ramp threads are missing from the stem, the likelihood of the set screw loosening from the radial stem intraoperatively is increased. If the set screw loosens, a revision surgery may be necessary. Biomet, Inc.
Devices BAG 9732315 MOUSE STERILE 15 PK Lot No.: 5246110712 5316560113 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices BIOPSY NEEDLE KIT, 9733068, PASSIVE Lot No.: 66516213 66501413 66518413 66507713 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices BIT 9733516 2.9mm DRILL STERILE Lot No.: 130204G Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices DISP 9730950 STRL SPHERE, 1 PK INSERT Lot No.: B135276281 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices DISP 9730951 STRL SPHERE, 5PK INSERT Lot No.: B155300281 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices DRAPE 9732722 TUBE STERILE O-ARM 20PK Lot No.: D120065 D121495 D121515 D120175 D122611 D101555 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices ENT PRGM 9734636 ADD FUSION NAV AxiEM Lot No.: 6917614 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices INST 9731132 KIT CR REF FRAME DRIVER 5PK Lot No.: r683 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices INSTRUMENT TRACKER 9733533XOM ENT 1PK Lot No.: 130904C 131203A 131003 131024B 130815 130904C 130510 130815 130708B 130815 130815 130716D 130204C 130418B 121128C 121218B 121218A 121128D 130409C 130409D 130123 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices KIT, 9731427, THORACIC TACTILE PROBES Lot No.: 6688089 6095124 6095129 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices MOUSE 9732721 STERILE O-ARM 10PK Lot No.: 5051140611 5336060213 5162060112 4734921009 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices PACK 9731975 TUMOR RESECTION AXIEM CR Lot No.: 0006922410 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT Lot No.: 121130B Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices PATIENT TRACKER 9733534XOM ENT 1PK Lot No.: 131212C 130827E 130827E 131113B 131203C 131113D 131018A 130212B 131105B 130429E 130815D 130815D 130815C 130409G 130409G 130510E 130422A 130410A 130510E 130409G Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices PIN, 9733235, 100MM, STERILE, PERC REF Lot No.: 2012110744 2013010347 2012081458 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices PIN, 9733236, 150MM, STERILE, PERC REF Lot No.: 2013041109 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices SHUNT KIT 9733605 NON-INVASIVE Lot No.: 120628B 130204E 130314H 121113H 130508B 130612A 130709 130325 130710 130729A 130826 130923B 131016C 131025F 130923B 131127A Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices SPHERES 8801071 1/TRAY 12PK Lot No.: 1203122 1205291 1206251 1306081 1309101 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices SPHERES 8801075 5/TRAY 12PK Lot No.: 1207251 1301091 1301081 1211141 1301151 1302051 1303141 1303121 1303191 1304031 1304081 1303071 1305221 1305281 1306181 1306231 1307041 1307051 1307111 1307131 1307121 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices TRAJ GUIDE KIT, 9733065, BIOPSY, EXT Lot No.: 0066225613 0066207713B 0066202413 0066212611 0066209012a 0066209012a Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices TRAJ GUIDE KIT, 9733066, BIOPSY, INT Lot No.: 0066233912C 0066201113B 0066212611B 0066233912C 066209012 066209012 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices TUMOR RES. PACK 9733553 AxiEM S.M. Lot No.: 6402019 6402024 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices TUMOR RESECTION KIT 9733607 NON-INVASIVE Lot No.: 120416C 121030D 130605B 121010F 130923C 131009A 130923C Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices TUMOR RESECTION KIT 9733608 SKULL MOUNT Lot No.: 120725D 130404B Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices UPGRD PRGM 9734638 ADD AxiEM NAVIGATION Lot No.: 6148186 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Drugs Laroscorbine Platinium (vitamin C/collagen) injectable I.V. solution, 1 gm/0.35 gm, 5 mL ampoules, packaged in 10-count ampoules per box, Laboratories Roche Nicholas S.A., F-74240 Gaillard, - Tel.: 04 50 87 70 70, Fabricant : Produits Roche, 52, Bld du Parc, 92521 Neulilly -sur-Seine Cedex, barcode *3421357* Lot #: F040, Exp 08/16 Class II Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote. Flawless Beauty LLC
Drugs Tatiomax (reduced glutathione/hydrolyzed collagen) powder for injection vials, 1200 mg/200 mg, 10-count vials per box, Manufactured by: Sujie Pharmaceutical Ltd., Tokyo, Japan, UPC 4973430081576 Lot #: UB302, Exp 05/12/15 Class II Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote. Flawless Beauty LLC
Drugs Saluta (reduced glutathione) Powder for Injection, 600 mg/vial, packaged in 10 vials per box, Exclusively Distributed by: QAF Pharmaceuticals Inc. Philippines, Unit Unit 202 ECG Building, Multinational Avenue, Multinational Village, Parahaque City, Metro Manila Philippines; Manufactured by: Shandong Luye Pharmaceutical Co. Ltd, Yantai Shandong, PRC la Luye Pharma Subsidiary, UPC 6920425209014 Lot #: 201302275, Exp 01/20/15; 201308384, Exp 10/19/2015 Class II Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote. Flawless Beauty LLC
Drugs Relumins Advanced Glutathione (lyophilized glutathione/vitamin C) injectable solution, 1500 mg/500 mg, packaged in 8-count vials, 8-count 5 mL vitamin C (ascorbic acid) solution diluent ampoules, and 30-count Advanced Glutathione Boosters capsules per box, Relumins Labs, 183 Locust Avenue, West Long Branch, NJ 07764, UPC 700175760302 Lot #: 130616, Exp 06/16 Class II Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used parenterally for drug claims. Flawless Beauty LLC
Drugs Vitamin C (ascorbic acid) Injection, USP, 500 mg per 2 mL, 50 x 2 mL ampoules per box, Manufactured by: TP Drug Laboratories (1969) Co., Ltd., 98 Soi Sukhumvlt 62, Yak 1, Bangchak, Prakanong, Bangkok 10260, Thailand, Reg. No. 1 A 1557/30; UPC 8 853533 000533 Lot #: 556273, Exp 9/25/16; 556219, Exp 8/2/16, or any other lot distributed by Flawless Beauty. Class II Marketed Without An Approved NDA/ANDA: Parenteral product is sold over the counter whose labeling indicates it is to be used for the treatment of disease. Flawless Beauty LLC
Drugs Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box, Manufactured and Distributed by: Euro Med Laboratories, UPC 4800573016219 Lot #: 16U394, Exp 04/16; 16U421, Exp 08/16; 16U423, Exp 09/16 Class II Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for parenteral injection. Flawless Beauty LLC
Devices Coaxial Micro-Introducer Kit, Greatbatch Part Number/Bard Access Systems Order Number/Part Description 10636-001 8004011 Kit Coax 10 Pack 4FR Bard; 10636-002 8005011 Kit Coax 10 Pack 5FR Bard; 10636-007 8004012 Kit Coax 10 Pack 4FR Bard; 10636-008 8005012 Kit Coax 10 Pack 5FR Bard; 10636-009 8004022 Kit Coax 10 Pack 5FR Bard; 10636-010 8005022 Kit Coax 10 Pack 5FR Bard. The Coaxial Micro-Introducer set contains a 21 gauge disposable introducer needle, 0.018 inch floppy tip guidewire, and a radiopaque Coaxial Micro Introducer consisting of a sheath and dilator. The Coaxial Micro-Introducer Set is used to introduce up to a 0.038 inch guidewire or catheter into the vascular system following a small 21 gauge needle stick. W1190519 W1190532 W1190532 W1190514 W1190517 W1190517 W1190516 W1266849 W1266851 W1266850 W1266848 W1298418 W1300005 W1298419 W1298425 W1298426 W1362771 W1362772 W1362773 W1362775 W1383678 W1362774 W1420240 W1420241 W1420242 W1434887 W1434888 W1464513 W1464514 W1464516 W1464511 W1464512 W1464515 W1466090 W1466092 W1466093 W1466091 W1467421 W1477933 W1467420 W1477935 W1477932 W1477934 W1490379 W1477937 W1490378 W1490380 W1490377 W1477936 W1509174 W1509175 W1532502 W1532501 W1509173 W1599234 W1629461 W1661254 W1688745 W1720426 W1746962 W1720428 W1792523 W1786461 W1788967 W1770099 W1807382 W1807383 W1807378 W1872468 W1872469 W1872470 W1927797 W1872468 W1927798 W1927799 W1963380 W2012849 W2012851 W2012850 W2047027 W2058073 W2047028 W2073401 W2047030 W2047031 W2094903 W2110798 W2170053 W2155950 W2170050 W2170052 W2192990 W2211695 W2211696 W2211697 W2268277 W2268271 W2315849 W2315850 W2315845 W2315846 W2315848 W2357893 W2357894 W2371770 W2371771 W2392043 W2357895 W2357896 W2397846 W2371772 W2386295 W2451688 W2451690 W2451691 W2451692 W2451693 W2461057 W2461056 W2461058 W2513845 W2561761 W2561762 Class II Greatbatch identified that the documentation does not support the five-year shelf life of the Bard Access Division Coaxial Micro-Introducer Set. Greatbatch Medical
Food Private Selection Chocolate Hazelnut Mascarpone Ice Cream, 16 fl oz lamented carton. Product labeled in part, "PRIVATE SELECTION" CHOCOLATE HAZELNUT MASCARPONE ICE CREAM chocolate covered hazelnuts folded into creamy mascarpone ice cream***INGREDIENTS: ICE CREAM MILK, CREAM SUGAR***MASCARPONE CHEESE (MILK, CREAM, CITRIC ACID)***CONTAINS: MILK, SOY, HAZELNUT***DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 UPC: 0 11110 52101 9 ALL CODES Class I The firm discovered that the label for two of their products did not declare eggs in the ingredient statement. Kroger Co
Food Private Selection Caramel Hazelnut Fudge Truffle Ice Cream, 16 fl oz lamented carton. Product labeled in part, "PRIVATE SELECTION" CARAMEL HAZELNUT FUDGE TRUFFLE ICE CREAM caramel, hazelnuts and fudge truffles folded into chocolate ganache ice cream***INGREDIENTS: ICE CREAM - MILK, CREAM SUGAR***CARAMEL VARIEGATE***CHOCOLATE TRUFFLES***CONTAINS: MILK, HAZELNUT, SOY. MAY ALSO CONTAIN: PEANUTS, WHEAT, TREE NUTS.***DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 UPC: 0 11110 52100 2" SELL BY AUG 02 14 and SELL BY DEC 13 14 Class I The firm discovered that the label for two of their products did not declare eggs in the ingredient statement. Kroger Co
Food Purity Organic - Organic Mango Mango Tommy Atkins CAT 1, Size 07, 08, 10 and 12. Product of Mexico, Pacific.com distributed by: Pacific Organic Produce, San Francisco, CA 94080 PLU 94051 and 94959; Lot 00017954 (not a retail pack) Class I IEH sample had positive result for Listeria Monocytogenes of Purity Brand Organic Fresh Mango. Pacific Organic Produce
Devices McKesson Radiology-PACS. McKesson Radiology is a medical image and information application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems. Model MR 12.0 Class II High priority alert icon was not displayed in the Study List when there are no Stat studies present. However, the High priority alert icon is visible when studies marked as Stat priority exist in the Study List. Mckesson Medical Immaging
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