Worldwide Distribution - USA (nationwide) and Canada
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids  Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration; and various solution through enteral, intravenous, intra-arterial, subcutaneous, and pathways.
button prior to completion of the programming. If this error occurs, a delay in therapy could occur and potentially result in significant injury.
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids    Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration; and various solution through enteral, intravenous, intra-arterial, subcutaneous, and pathways.
BDN pet foods Chicken Supreme, packaged in 1 lb. and 5 lb. pouches and 10 lb. vacuum bags,   BDN Pet Foods, Inc. 1121 Industrial Parkway Suite D Brick, NJ 08724   FOR INFO: Email info@bigdognatural.com  CALL 732-785-2600 - TOLL FREE 877 K9 MEATS
Dog food may be contaminated with Salmonella and Listeria monocytogenes as per FDA sampling and analysis.
all products shipped from 10/31/2015 to 11/13/2015
BDN pet foods Fish Supreme, packaged in 1 lb. and 5 lb. pouches and 10 lb. vacuum bags,  BDN Pet Foods, Inc. 1121 Industrial Parkway Suite D Brick, NJ 08724   FOR INFO: Email info@bigdognatural.com  CALL 732-785-2600 - TOLL FREE 877 K9 MEATS
Product was distributed to one customer in NE.
Meyer Calf Starter 18 Pellets B68 Medicated.  For all classes of calves up to 200 pounds.  Active Drug Ingredient Lasalocid (34 mg/lb) 68 g/ton.  Product is shipped in bulk.  The responsible firm name on the label is Progressive Nutrition, Norfolk, NE 68701.
Product contains elevated levels of monensin.
none; distribution date from November 2015 to 1/29/16
Porfirio's 6 Cheese Manicotti Net Wt. 22 oz.  Manufactured by Porfirio's Italian Food, Inc. 320 Anderson Street, Trenton NJ 08611
Pasta Products which contain cheese may contain undeclared wheat and milk.
Porfirio's Cheese & Spinach Manicotti Manufactured by Porfirio's Italian Food, Inc. 320 Anderson Street, Trenton NJ 08611
Porfirio's Potato Gnocchi Net Wt. 16 oz. (1 LB.) 453 g  Manufactured by Porfirio's  Italian Food, Inc. 320 Anderson Street, Trenton NJ 08611 UPC 016105000319
Porfirio's 12 Jumbo Cheese Ravioli Net Wt. 14 oz. Manufactured by Porfirio's Italian Food, Inc. 320 Anderson Street, Trenton NJ 08611
Porfirio's Homeade Ricotta Gnocchi Net Wt. 16 oz (1 LB.) 453 g Manufactured by Porfirio's Italian Food, Inc. 320 Anderson Street, Trenton NJ 08611 UPC 016105000319
Porfirio's Egg Fettucine   Manufactured by Porfirio's Italian Food, Inc. 320 Anderson Street, Trenton NJ 08611
Porfirio's 12 Jumbo Spinach Ravioli  Net Wt. 14 oz. (1 LB.) 453 g Manufactured by Porfirio's Italian Food, Inc. 320 Anderson Street, Trenton NJ 08611
Porfirio's 12 Jumbo Stuffed Shells Net Wt. 24 oz.  Manufactured by Porfirio's Italian Food, Inc. 320 Anderson Street, Trenton NJ 08611
Porfirio's Homeade Ricotta Cavatelli  Net Wt. 1Lb Manufactured by Porfirio's Italian Food, Inc. 320 Anderson Street, Trenton NJ
Shipped to distribution centers in California and subsequently to retail stores in CA, HI, NV, and OR.
MannaPro Chick Starter Medicated, Amprolium 113.5 g/ton, UPC 0 95668 10555 6, packaged in 25 lb woven plastic bags.  Manufactured by MannaPro Products LLC. St. Louis, MO
Product contains excessive levels of salt.
Worldwide Distribution-USA (nationwide) and countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.
VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598    For in vitro diagnostic use only. For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System when used for the in vitro qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma (heparin, EDTA or citrate). The performance of the VITROS Immunodiagnostic Products HBsAg Controls has not been established with any other HBsAg assay.
The signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the allowed 5 days.  Increased results may occur on both the negative and positive Controls.  The positive Control, although showing elevated results, was still within acceptable performance.
SimpliRED D-Dimer, Product Code DSRK4  The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood
A component of the kit is showing a sensitivity performance detected in stability testing at 15 months of an 18-month shelf life.  Qualitative results may be affected.  False negative results are possible which may incorrectly influence the clinical diagnostic decision.
Lot Numbers containing test reagent lot # 1012-34437): BU183A, BU183B, BU184A, BU185A, BU185B  Expiration Date: 31 JUL 2016
Nationwide Distribution to AL, CA, FL, GA, IL, IN, KY, MO, MS, NC, NV, NY, PA, SC, TN, TX,  and WV.
Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03  Neptune Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incision. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis and in patients on anticoagulation therapy
Worldwide distribution- US (Nationwide) and countries of: United Arab Emirates, Afghanistan, Angola, Argentina, Australia, Bangladesh, Belgium, Bulgaria, Bahrain, Bolivia, Brazil, Belarus, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Germany, Dominican Republic, Algeria, Ecuador, Egypt, Spain, France, Great Britain, Greece, Guatemala, Honduras, Hungary, India, Iraq, Italy, Jordan, Canary Islands, Kyrgyzstan, Rep. Korea (S), Kazakhstan, Lebanon, Lithuania, Luxembourg, Latvia, Macedonia, Mexico, Malaysia, Nicaragua, Netherlands, Norway, Nepal, Peru, Pakistan, Poland, Portugal, Paraguay, Qatar, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, El Salvador, Syria, Turkmenistan, Tunisia, Turkey, Uruguay, Uzbekistan, Vietnam, Serbia,and South Africa.
IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material Number (SMN) 10370301 (US), Unique Device Identification Number (UDI) 00630414985718 (US); and  REF/Catalog Number LKCM1 - 100 tests (OUS); SMN 10381296 (OUS), UDI 00630414963747 (OUS); IVD --- Made in UK Siemens Healthcare Diagnostics Products Ltd., Glyn Rhonwy, Llanberis, Gwynedd, LL55 4EL UK    For in vitro diagnostic use with the IMMULITE Systems Analyzers for the qualitative detection of IgM antibodies to Cytomegalovirus (CMV) in human serum or plasma (EDTA or heparinized), as an aid in the determination of an acute CMV infection.
Multiple customers reported seeing an increase in imprecision with some patients resulting in high % CVs with the IMMULITE 2000/2000XPi CMV (IgM) assay starting with reagent lots 259 and above.
IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/Catalog Number L2KCM2(D) - 200 tests (US), SMN 10370302 (US), UDI  00630414985725 (US); and REF/Catalog Number L2KCM2 - 200 tests (OUS), SMN 10371320 (OUS), UDI 00630414961163 (OUS); IVD ---   Siemens Healthcare Diagnostics Products Ltd., Llanberis, Gwynedd, LL55 4EL UK    For in vitro diagnostic use with IMMULITE 2000 analyzers for the qualitative detection of IgM antibodies to cytomegalovirus (CMV) in human serum or plasma (EDTA or heparinized), as an aid in the diagnosis of current and recent CMV infection in individuals with signs and symptoms of CMV infection or clinical suspicion of CMV infection. This assay is not FDA cleared or approved for use in testing (screening) blood or plasma donors, neonatal screening, or for use at point-of-care facilities.
Multiple customers reported seeing an increase in imprecision with some patients resulting in high % CVs with the  IMMULITE 2000/2000XPi CMV (IgM) assay starting with reagent lots 259 and above.
A. Love's Bakery (Distributor)  911 Middle St. 	  Honolulu, HI, 96819	  Phone: (808) 841-2088  Contact: Byron Chong / Director of Sales and Marketing    B. Seafood City Supermarket, Hawaii  (Retail)  94-050 Farrington Hwy.   Waipahu, HI 96797  Phone: (808) 675-2350  Contact: Michael Solis / Store Manager
[UPC#78253230919]: Packaged in a clear plastic bag, containing eight pieces, with a net weight of 14 ounces. This product contains: eggs, wheat, milk, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6)
Regalo Bakery is recalling Spanish Rolls due to undeclared eggs, wheat, milk, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6).
[UPC#78253230917]  packaged on a foam tray with six pieces each, wrapped in clear plastic film. This product contains: eggs, wheat, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6)
Regalo Bakery is recalling Manju Blackbeans (Hopia Monggo due to undeclared  eggs, wheat, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6).
[UPC#78253203095] : Packaged on a foam tray, containing four pieces, wrapped in clear plastic film, and have a net weight of  16 ounces. This product contains: eggs, wheat, milk, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6).
Regalo Bakery is recalling Balintawak due to undeclared eggs, wheat, milk, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6).
[UPC#78253230920]: Packaged on a foam tray, containing six pieces, and wrapped in a clear plastic film. This product contains wheat, milk, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6).
Regalo Bakery is recalling Kababayan due to undeclared wheat, milk, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6).
[UPC#78253231001] : Packaged in a clear plastic bag, containing twelve pieces, and have a net weight of 20 ounces This product contains This product contains: eggs, wheat, milk, soy, coconut, and artificial food coloring (Red 40 & 3, Yellow 5 & 6, Blue 1).
Regalo Bakery is recalling Taro Bread due to undeclared  eggs, wheat, milk, soy, coconut, and artificial food coloring (Red 40 & 3, Yellow 5 & 6, Blue 1).
[UPC#78253230918]: packaged on a foam tray with six pieces each, wrapped in clear plastic film. This product contains: eggs, wheat, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6)
Regalo Bakery is recalling Manju Onions (Hopia Baboy) due to undeclared eggs, wheat, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6).
Wilton Pink Airbrush Color, Net Wt 0.64 FL OZ (19 mL)
Airbrush color has the potential to be contaminated with mold, yeast or bacteria.
Wilton Purple Airbrush Color, Net Wt 0.64 FL OZ (19 mL)
Wilton Yellow Airbrush Color, Net Wt 0.64 FL OZ (19 mL)
Wilton Red Airbrush Color, Net Wt 0.64 FL OZ (19 mL)
Wilton Blue Airbrush Color, Net Wt 0.64 FL OZ (19 mL)
Airbrush color found to contain mold, yeast, or bacteria
Wilton Gold Airbrush Color, Net Wt 0.64 FL OZ (19 mL)
Wilton Teal Airbrush Color, Net Wt 0.64 FL OZ (19 mL)
Wilton Silver Airbrush Color, Net Wt 0.64 FL OZ (19 mL)
Airbrush color found to contain mold, yeast or bacteria
Wilton Black Airbrush Color, Net Wt 0.64 FL OZ (19 mL)
Wilton Brown Airbrush Color, Net Wt 0.64 FL OZ (19 mL)
Wilton Green Airbrush Color, Net Wt 0.64 FL OZ (19 mL)
Wilton Pearl Airbrush Color, Net Wt 0.64 FL OZ (19 mL)
Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
There is a potential for the needle to detach from the suture thread during surgery.  If the needle becomes detached the defective suture will need to be replaced causing the wound to be sutured a second time.
New York and New Jersey via retail stores
OSSIE'S EGG WITH SCALLION, NET WT. 7 OZ., UPC 73988570555; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
The products have the potential to be contaminated with Listeria monocytogenes based on the findings of the bacteria in the plant via FDA environmental sampling plus the district's inspectional findings
Best By date codes of 08/21/16 through 10/18/16
OSSIE'S HERRING IN SOURCREAM, NET WT. 8 OZ., UPC 739885114714; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
OSSIE'S DUBLIN HERRING, NET WT. 7 OZ., UPC 739885109002; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
OSSIE'S PICKLED LOX DAIRY, NET WT. 8 OZ., UPC 739885114136; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
OSSIE'S HOME MADE TUNA SALAD, NET WT. 7 OZ., UPC 73988570550; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
OSSIE'S EGG SALAD, NET WT. 7 OZ., UPC 73988570552; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
OSSIE'S PICKLED HERRING, NET WT. 8 OZ., UPC 739885104175; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
OSSIE'S PICKLED LOX, NET WT. 8 OZ., UPC 739885104137; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
OSSIE'S TAAM SHABBOS HERRING, NET WT. 7 OZ., UPC 739885109057; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
OSSIE'S HONEY MUSTARD HERRING; NET WT. 7 OZ. 739885109019; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
OSSIE'S STIGLITZ HERRING, NET WT. 7 OZ., UPC 739885109064; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
OSSIE'S SWEDISH MATJES HERRING, NET WT. 7 OZ., UPC 739885109101; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
OSSIE'S SHMALTZ HERRING, NET WT. 8 OZ., UPC 739885104182; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
OSSIE'S EGG WITH MUSHROOM, NET WT. 7 OZ., UPC 73988570556; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
OSSIE'S PICKLED HERRING CLEAR, NET WT. 8 OZ., UPC 739885104205; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
OSSIE'S LITE TUNA, NET WT. 7 OZ., UPC 73988570551; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
OSSIE'S PICKLED LOX & CREAM, NET WT. 8 OZ., UPC 739885104113; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
OSSIE'S WASABI HERRING, NET WT. 7 OZ., UPC 739885109088; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
OSSIE'S ROMAN SHMALTZ HERRING, NET WT. 7 OZ., UPC 739885109026; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Worldwide Distribution-(Nationwide) and foreign distribution to the following countries: Belgium, Bermuda, Canada, Chile, Denmark, France, Italy, Mexico, Norway, Portugal, Sweden, Taiwan and United Kingdom.
enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module and TCAutomation Software Version 3.6.1 and Below; IVD. --- Thermo Scientific Centrifuge Module has Product Code   952040-EG 6844097.    The VITROS 5,1 FS Chemistry System with enGen Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods).
Software Versions 3.6.1 and below;  Affected US Serial Numbers: 5GV6W2J,GBX395J, J2QKG25J, 2Z3YV1J, 3RHC23J, 4HX7S4J, 54FC01J, 5J4B45J, 736BM4J, 7KSC15J, J86PWC5J, 953209, 953221, 953266, 953270, B3ZHP2J, CXL941J, JFBX395J, FCM073J, FXCBG3J, JG7BFB5J, GWXQ52J, HJ5K84J, HPKG25J -- Affected Foreign Serial Numbers: DWXO52J, GWJZY4J, J16XQH4J, BGV6W2J, 17QP94J, 4SHPF4J, 1K5K84J, 37QP34J, H5PWC5J, J2V6LW4J, F6MXR3J, JT6LW4J, N0551107, F1150698, 46XQH4J, 2S5OP0J, CRKM82, J41BCY4J, J56T205J, BGV6W2J, 7YCF43J, 96XQHAJ, C1JNZ5J, C3JTP4J, D3JTP4J, 86T205J, 18BFB5J, 96PWC5J, 1LSSF5J, 4drj44j, 8W7WG3J, J953222, J953244, JCT20Q3J, HWJZY4J, 38769917923.
VS II Aliquoter System  calculator/data processing module, for clinical use    Product Usage:  Elecysy 411 analyzer is a fully automated, random access, computer controlled analytical systems for quantitative and qualitative determinations of analytes in body fluids.
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an  analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.
Roche COBAS INTEGRA 800 /800 CTS Analyzer  Analyzer, Chemistry (Photometric, Discrete for Clinical use    Product Usage:  The system cobas p612 is a computer-controlled stand-alone system for aliquoting and sorting of barcoded sample tubes. The system operates with an online connection to the host.
cobas p 501 Post-Analytical Unit  calculator/data processing module, for clinical use    Product Usage:  The MODULAR PRE-ANALYTICS system is a fully automated system for sample pre-processing, including centrifuging, aliquoting, and barcode labeling, prior to analysis by MODULAR SYSTEMS analyzers.
cobas p 312 Pre-Analytical System  calculator/data processing module, for clinical use    Product  Usage:  The cobas p471 system is an automatic centrifuge module for centrifuging primary sample tubes, which will then be transported to the output module.
cobas 6800/8800 system  Hepatitis Viral B DNA Detection    Product Usage:  The cobas p512 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged sample tubes. It includes modules for registration and decapping of sample tubes, liquid level detection (optional) and sample quality detection (optional), as well as recapping of sample tubes (optional).
RSD 800A Aliquoting System  calculator/data processing module, for clinical use    Product Usage:  The Roche/Hitachi MODULAR Analytics System is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests.
cobas p 471 centrifuge unit  calculator/data processing module, for clinical use    Product Usage:  The cobas p312 pre-analytical system is a computer controlled stand-alone system for sorting and decapping sample tubes. As an option, the system works with an online connection.
cobas 8000 Modular Analyzer Series  c8000, Chemistry (Photometric, Discrete) for clinical use Modular e602: Immunoassay Analyzer    Product Usage:  The VS II system is a stand-alone, computer-controlled instrument designed to aliquot patient sample from a primary tube to a barcoded secondary tube for processing on an off-line analyzer.
cobas 6000 Series system  c6000, Chemistry (Photometric, Discrete), for clinical Use. Modular e601: Immunoassay Analyzer    Product Usage:  The cobas p501/p701 instrument stores primary and secondary sample tubes. The tubes are stored in a controlled, refrigerated sample store. Automatic retrieval for add-on testing is possible at any time. Expired samples are disposed of automatically when their storage time has elapsed. The instrument is intended as accessory for diagnostic use.
Roche/Hitachi MODULAR Analytics Combination Systems  Modular D/P: Clinical Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use. Modular E170: Immunoassay Analyzer    Product Usage:  The Roche COBAS INTEGRA 800/800 CTS Analyzer is fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids.
cobas e411 Immunoassay Analyzer  e411: Immunoassay Analyzer    Product Usage:  The cobas p501/p701 instrument stores primary and secondary sample tubes. The tubes are stored in a controlled, refrigerated sample store. Automatic retrieval for add-on testing is possible at any time. Expired samples are disposed of automatically when their storage time has elapsed. The instrument is intended as accessory for diagnostic use.
cobas p 512 Pre-Analytical Instrument  calculator/data processing module, for clinical use    Product Usage:  The cobas 6800/8800 systems support an automated and integrated workflow to run Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) to be applied in diagnostic laboratories.
cobas p 701 Post-Analytical Unit  calculator/data processing module, for clinical use    Product Usage:  The URISYS 2400 Analyzer is a fully automated urinalysis system intended for in vitro qualitative or semi-quantitative determination of urine analytes, including pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, and erythrocytes, In addition, the analyzer determines specific gravity, color, and clarity. The URISYS 2400 is intended for professional use only.
URISYS 2400 Urine Analyzer  Automated Urinalysis System    Product Usage:  The RSD 800 is a computer-controlled stand-alone sorting system for sorting barcoded samples. The system has an online connection to the host.
RSD 800 Sorting System  calculator/data processing module, for clinical use    Product Usage:  The cobas 8000 Modular Analyze Series is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.
Modular Pre Analytics ( EVO/Plus)    Product Usage:  The RSD 800A is a computer-controlled stand-online system for decapping, aliquoting and sorting of primary tubes and for producing and sorting bar coded secondary tubes.. The system operates with an online connection to the host.
cobas p 612 Pre-Analytical Instrument  calculator/data processing module, for clinical use    Product Usage:  The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module.
NE, WI, IL, IN, WA, MO, IA, FL, MN, OH, TX, MI, MT, SC, CA (individual in CA is a sales rep for the firm and received one case of product for marketing purposes).
BRACH'S Chocolate Creations, Milk Chocolate Almond Supremes, Fresh roasted almonds drenched in rich creamy milk chocolate.  NET WT 5 oz (142 g).  Best By 04/22/2017
Undeclared peanuts and wheat in product.
Worldwide Distribution - US including NY, MN, FL, MO, MD, TN, NC, OH, CA, KS, TN, WV and Internationally to Czech Republic, Germany, UK, France, Netherlands, Italy, Spain, Finland, Switzerland, Slovenia, Hungary, Northern Ireland, Turkey, and Denmark,
VIA 27 Microcatheter,  Part No. FG27-154-01, Model No. VIA-27-154-01    The VIA 27 is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or therapeutic agents into the neuro, peripheral, and coronary vasculature. The catheter is inserted into the body through a small puncture made in the skin and into a blood vessel. The VIA 27 Microcatheter is contraindicated for use with liquid embolic materials, such as n-butyl 2-cyanoacrylate or ethylene vinyl alcohol & DMSO (dimethyl sulfoxide).
Sequent Medical is recalling the VIA 27 Microcatheter because it may not adequately re-sheath the interventional device into the catheter as designed.
Worldwide distribution - US (Nationwide Distribution to CA, CO, IL, MA, MN, ND, NY, NV, PA, and VA.) and Italy
Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Nationwide Distribution -- AR, CA, DC, GA, HI, ID, IL, IN, LA, ME, MD, MA, MI, MN, MO, NE, NJ, NM, NY, NC, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, and WV.
ex-TEM Assay for ROTEM delta Thromboelastometry System.  Art. no.: 503-05 US, ex-tem.    Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM delta.
Customers complained of low/empty reagent vials.
Tri-Vitamin, 50 mL, OTC Non-Sterile.  Dietary supplement.
Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.
Polyvitamin Liquid with Iron, 50 mL, OTC Non-Sterile.  Dietary supplement.
D3 Vitamin Liquid, 50 mL, OTC Non-Sterile.  Dietary supplement.
D-Vita Drops, 50 mL, OTC Non-Sterile.  Dietary supplement.
Virtrate-2, Sodium Citrate-Citric Acid, 16oz./473 mL, OTC Non-Sterile. Dietary supplement.
Ferrous Sulfate Liquid, 16 oz./473 mL, OTC Non-Sterile.  Dietary supplement.
Ferrous Drops, 50 mL, OTC Non-Sterile.  Dietary supplement.
Calcionate Syrup, Calcium Glubionate Syrup, 16 oz./473 mL, OTC Non-Sterile.  Dietary supplement.
Pedia D-Vite Drops, 50 mL, OTC Non-Sterile.  Dietary supplement.
Pedia Tri-Vite Drops, 50 mL, OTC Non-Sterile.  Dietary supplement.
CytoDetox, Hydrolyzed Clinoptilolite Fragments, 1 oz./30 mL, OTC Non-Sterile.  Dietary supplement.
Liquid Vitamin C, 4 oz./118 mL, OTC Non-Sterile.   Dietary supplement.
Fer-Iron Liquid, 50 mL, OTC Non-Sterile.  Dietary supplement.
Virtrate-K, Potassium Citrate and Citric Acid, 16oz./473 mL, OTC Non-Sterile.  Dietary supplement.
Poly-Vita Drops with Iron, 50 mL, OTC Non-Sterile.  Dietary supplement.
Pedia Tri-Vite Drops with Iron, 50 mL, OTC Non-Sterile.  Dietary supplement.
Poly-Vita Drops, 50 mL, OTC Non-Sterile.  Dietary supplement.
Renew HC, Hydrolyzed Clinoptilolite, 1 oz./30 mL, OTC Non-Sterile.  Dietary supplement.
Tri-Vita Drops, 50 mL, OTC Non-Sterile.  Dietary supplement.
Pedia Poly-Vite Drops, 50 mL, OTC Non-Sterile.  Dietary supplement.
Cerovite Liquid, 8 oz./236 mL, OTC Non-Sterile.  Dietary supplement.
CertaVite with Antioxidants, 8 oz./236 mL, OTC Non-Sterile.   Dietary supplement.
Polyvitamin Liquid, 50 mL, OTC Non-Sterile.  Dietary supplement.
Blood products, which did not meet the acceptable product specifications, were distributed.
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
Product is packaged in multilayered flexible film with multiple colors.  Firm brand name is printed in red.    Case contains 8/8 oz. packages.    UPC 0 39978 00554 0 or  0 39978 00554 1
The firm is voluntarily recalling one lot of Guar Gum due to due to the inclusion of a misidentified ingredient, hydroxyethylcellulose.
Blood product, collected from a donor whose donor suitability was not adequately determined, was distributed.
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Apheresis Platelets, Leukocytes Reduced, Irradiated
Blood product, which did not meet acceptable product specifications, was distributed.
Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract including the esophagus, stomach and duodenum.
Pentax is initiating the product removal of several model numbers of Pentax's Gastroscopes that were shipped between the clearance date of April 2014 and September 2015 because they contain the operation and reprocessing IFU's that were in use prior to the 2014 clearances and therefore did not include the cleared operation IFU, the updated reprocessing IFU or the dedicated reprocessing adaptor (for applicable models).
Blood product, with a low platelet count, was distributed.
Del Monte Research Center - Walnut Creek
DM Light Slices Yellow Cling Peaches -15 oz (425g) 300 x 407
Between September 7 thru September 29, 2016, consumer complaints led firm to believe that cans of Lite Sliced Peaches were mislabeled as they appeared to contain Fruit Cocktail in Heavy Syrup. The label on the can states Lite Sliced Peaches (Yellow cling peach in Extra Light Syrup) and the product inside contains Fruit Cocktail in Heavy Syrup. Fruit Cocktail contains cherries colored with carmine. FDA regulations requires carmine to be labeled due to its potential allergen status (21 CFR 73.100 (d)(2)).
Nationwide.  CANADA  HONG KONG  KOREA  SINGAPORE  CHINA  VENEZUELA  AUSTRALIA  JAPAN  NETHERLANDS  GERMANY  INDIA  TAIWAN
Patellofemoral Joint Prosthesis  Milling Handpiece
Complaints have been reported that the handpiece is inoperable. The investigation found that the complaints were related to the lack of preventative maintenance contrary to what is recommended in the instructions for use included with the handpiece. An inoperable device may lead to a delay in surgery
Item Number  00-5927-040-00  Serial Number  All
DIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle, Rx only, Dist. by: Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-0436-25
Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and  50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.
Persantine (dipyridamole USP) tablets, 75 mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT  06877, NDC 0597-0019-01
BD has contacted all 31 US customers and 22 Ex-US sites which received product from the associated catalog numbers.    US:  AL, CA, CO, KY, MD, MI, MS, NE, NJ, OH, PA, SC, SD, TX, VA, WA and WI.    Ex-US:  Argentina, Europe, Canada, China, Ecuador, India, Japan, New Zealand, Peru, Singapore, Thailand and Vietnam    4 US government sites were contacted
PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec &#38 Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland standards 0.10 to 4.50.
BD has determined that the BBL PhoenixSpec Calibrator kits referenced in this recall from the following lots (5364776, 5345796 ) are labeled with an incorrect expiration date (year).  The expiration date printed on the individual calibration tubes within the kit are correct but difficult to read on a portion of the tubes.
PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec &#38; Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland standards 0.10 to 4.50.
BD has determined that the PhoenixSpec AP Calibrator referenced in this recall from the following lot (5327782) are labeled with an incorrect expiration date (year).  The expiration date printed on the individual calibration tubes within the kit are correct but difficult to read on a portion of the tubes.
Part/Catalog Number.: 440911    Lot / Serial Number. 5327782
AccessClosure, Inc., A Cardinal Health Company
The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed for use in the iliofemoral artery to provide temporary occlusion as well as a path for dilator and/or sheath introduction, removal or repositioning during catheterization procedures.
AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE Occlusion Balloon System device   because it was made aware from customers that the device may be removed in the absence of vascular sheath across the arteriotomy.  This is a deviation from the firm's standard catheterization technique.
Product Model ACX101,  Manufacturer UDI *+ M465ACX10106*    Lot No: F1614503
Worldwide Distribution -- USA, Italy, Russian Fed., Australia, United Arab Emirates, Spain, United Kingdom, India, Kuwait, and Belarus.
Tip (SPSA-20002590)    Provide fractional treatments in gynecology.
Nationwide Distribution.  Not distributed to any Foreign Countries or Governmental Agencies.
Club Size McCormick Original Taco Seasoning Mix 24 oz. ,   CASE PACK: 12/case
14,570 individual 24 ounce containers are in commerce.
Product was recalled due to undeclared milk.
UPC NUMBER:  52100302461  MCCORMICK ITEM NUMBER:  930246 or 900272507  SCC NUMBER ON SHIPPER: 52100302461 or 52100012476    AFFECTED DATE CODE FOR FOLLOWING ITEM NUMBERS:  932046 - BEST BY JUL 08 18 H through BEST BY SEPT 16 18 H; 900272507 - BEST BY JUN 27 18 H through BEST BY SEPT 16 18 H
Worldwide Distribution - US (nationwide) and OUS
Fortify VR, Model No. CD1231-40, CD1231-40Q.  Fortify ST VR, Model No. CD1241-40, CD1241-40Q.  Fortify Assura VR, Model No. CD1257-40, CD1257-40Q, CD1357-40C.  Fortify Assura ST VR, Model No. CD1263-40, CD1263-40Q, CD1363-40, CD1363-40Q.  Fortify DR, Model No. CD2231-40, CD2231-40Q.  Fortify ST DR, Model No. CD2241-40, CD-2241-40Q, CD2263-40, CD2363-40C, CD2363-40Q.  Fortify Assura DR, Model No. CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q.  Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization  therapy defibrillator (CRT-D) devices because they are subject to premature battery depletion due to lithium cluster with the battery causing a short circuit.
Unify, Model No. CD3231-40, CD3231-40Q.  Unify Quadra, Model No. CD3249-40, CD3249-40Q.  Unify Assura, Model No. CD3257-40, CD3357-40C, CD3357-40Q.  Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing.
Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q.  Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C.  Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
United States Only. See consignee lists.
Nestle Drumstick Club variety -  16x4.6floz US  UPC# 72554-11096  Best Before Date: Between June 2 - June 15, 2017
Nestle Drumstick Vanilla pack- 24x4.6fl oz US  UPC# 72554-00160  Best Before Date: Between June 16 - June 19, 2017
US Distribution to the states of : NY, NJ,  NV, NE,  IL, CT, PA and ME
29 units , plus 47 wing handles were shipped as spare parts
US Nationwide Distribution in the states of: CA, IN, HI, CT, UT, WA, FL, VA, WI, OH, MN, KS, MD, IL, MO, WY, MT, ME, PA, TN, MI, OR, NY, NJ, ID, NC, IA, OK, AR, VT, SC, TX
4205 Journey Rolling Walker     Product Usage:  used to assist people in walking
Nova Medical is recalling the Journey Rolling Walker because the screws used to hold the black side support pieces to the frame can become loose over time. This can result in the locking nut coming off and the screw falling out.
Serial No.  YA 4205RDFG004 TO YA4205RDFG0098  YZ4205BKFC0002 TO YZ4205RDFE0100
Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-count bottle, Rx only,  Finished product manufactured by: Janssen Ortho, LLC, Gurabo PR 00778, Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, NJ 08560, NDC 50458-543-60
Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the exterior of Invokamet bottles in place of the Invokamet prescribing information outsert.
Australia, Austria, Belgium, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Monaco, Netherlands, Norway, Portugal, Puerto Rico, Qatar, Romania, South  Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States
Surgical System, model number IS4000, A70_P5x with P5 Software;    General and Plastic Surgery:  The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders,  endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic  surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures.
Intuitive Surgical has identified a software anomaly in the da Vinci Xi P5 software that can result in  unexpected master movement and potential instrument tip movement under certain circumstances
All systems manufactured with or upgraded to P5 software.