Blood products, collected in a manner that may have compromised sterility, were distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Product was shipped to the following states: AL, GA, IA, IL, IN, KY, MA, MD, MI, MN, MS, NC, ND, NJ, NY, OH, PA, SC, TN, VA, VT, WI & WV.
WHOLESOME NUTRITION PMI NUTRITION RED FLANNEL PET FOOD CAT FORMULA CAT FOOD NET WT. 20 LB (9.07 kg) Distributed exclusively through PMI Nutrition Dealers. made in the USA Manufactured for PMI Nutrition LLC Brentwood, Missouri 63144 800 332-4738 www.pminutrition.com UPC 7 42869 00058 5 Item Number: 0066520 9902 2890652
The firm was notified by the FDA of a positive result for Salmonella.
The product was distributed in CA, HI and NV. Distribution was also made to a military customer.  There was no foreign distribution.
Hill's Science Diet Adult 1-6, Small & Toy Breeds, Premium Natural Dog Food, packaged in 15.5 lb (7.03 kg) bags. Manufactured by: Hill's Pet Nutrition, Inc., Topeka, KS.
The product may be contaminated with Salmonella.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Tasty Peach Slices, NET WT. 3.87 OZ (110g), UPC 6 949663 601787 -- Product of China --- The product was packed in a clear plastic bottle/jar. --- 12.75 mg sulfites per serving.
The dried fruit product contained undeclared sulfites (225.0 ppm) based on sampling and analysis by New York State Department of Agriculture and Markets.
US Distribution to the states of : NY, CA, WA, PA, MD, AL, FL and LA.
GE Optional Laser Centering Device  X-ray generator.
GE has identified a potential failure to comply with 21 C.F.R.  1040.10 and 21 C.F.R.  1010.2 for the alignment laser centering device.
James G. Cole, Inc., dba ASN/Maxam Neutraceutics
ALL MAXAM PRODUCTS: The Maxam product is used orally in spray form and bears the Maxam label.     ********The List of MAXAM products**********************************************    AD   Nutritional Support for a Positive Outlook;  AFX   Nutritional Support for Healthy Cellular Function;  ANANDA   Nutritional Support for Emotional & Muscular Well-Being;  ANAVONE   Nutritional Support for Healthy Stress Management;  ANACORT   5 Methyl 7 Methoxyisoflavone;  BCAA   Branched Chain Amico Acids. Nutritional Support for Muscle Growth;  BIOGUARD   Nutritional Support for Gastrointestinal Health;  B-MAX   Nutritional Support for Endogenous B Vitamins;  CELLAFLEX  Nutritional Support for Joints, Skin & Connective Tissue;  CO-Q10 Nutritional Support for Endogenous Co-Q10;  CREOCELL  Nutritional Support for Endogenous Creatine Phosphokinase (CPK);  CYTOMUNE Nutritional Support for Healthy Immune Function;  C-60  Fullerine. Nutritional Support for Antioxidant Activity;  DEEP SLEEP;   ENDOTROPIN;   FGF Fibroblast Growth Factor.  Nutritional Support for Endogenous;  FGF;  GTF;   HCG Nutritional Support for Endogeous HCG;  HIGH CHI;   H-PLUS H-Plus Hydrogen. Nutritional Support for Health Cellular Antioxidant Activity;  KETOPLEX Nutritional Support for Women's Hormonal Health;  LIV Nutritional Support for Liver Health;  MAXATROPIN Nutritional Support for Hormonal Health in Men & Women;  MYOTROPIN  Myostatin Inhibitor. Nutritional Support for Healthy Muscle Regeration;  NADH Nutrional support for Healthy Mitochondrial Function;  NATURAL PASSION;   NERVEX Nutritional Support for Healthy Nerve Function;  NEUROGEN Nutritional Support for Healthy Brain Function;  OSTEOREN Nutritional Support for Health Teeth & Bones;  OXYCHARGE Nutritional Support for Aerobic Metabolism & Endurance;  OXYTOCIN Nutritional Support for Endogenous Oxytocin;  PC3 Nutritional Support for Toxin & Waste Elimination 3 Ways;  PCA Nutritional Support for Natural Toxin & Waste Elimination;  PCR;   PHP Paleolithic Human Probiotics. Probiotic & Post Biotic;  PI
All Maxam brand products are recalled because it was ordered by the United States District Court for the District of Oregon.  Products are also recalled due to misbranded, adulterated, and unapproved new drugs because of certain claims about their effects had not been approved by the FDA.
ALL ASN products: The ASN products are in capsule or powdered form and bear the ASN label.     *********the List of ASN products*****************************    AFINITY WHEY PROTEIN;   DHEA;   HUMAGRO Homeopathic Growth Hormone 4c;  PHYTOBOL;   TESTRX;   TRIBESTRONE II;
All ASN brand products are recalled because it was ordered by the United States District Court for the District of Oregon.  Products are also recalled due to misbranded, adulterated, and unapproved new drugs because of certain claims about their effects had not been approved by the FDA.
Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, packaged in 5 x 2 mL vials per carton, Rx only, labeled as a) Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY  10017, NDC 0069-0146-01; and b) Manufactured for: Mylan Institutional LLC, Rockford, IL  61103, NDC 67457-467-99.
Presence of Particulate Matter: observed during testing of retained samples.
Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-0152-01), packaged in 10 x 5 mL Vials per carton (NDC 0069-0152-02), Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY  10017.
Platelets, lacking proper quality control testing, were distributed.
US Nationwide in the states: AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI &  WY and the country of Mexico.
Oasis Coil Extension Cable used with Hitachi Oasis MRI System   Product Usage:  The Oasis MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The Oasis system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination. The Coil Extension Cable that is the subject of the removal action is an accessory that is used in conjunction with certain anatomy coils to aid in patient positioning.
The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard if touched.
ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818.  Orthopedic manual surgical instrument.     Howmedica Osteonics Corp.   A Subsidiary of Stryker Corp.  Stryker France    Non-sterile    Made in Cork Ireland
A package labeled as  Part #5901-S-4818, Lot MAC7C14, standard humeral head trial, contained part # 5901-E-4818 Lot MAC7C14, offset humeral head trial.
U.S. distribution to the following; CA, IL, and NJ. No foreign distribution.
Baked Seasoned Sardine Okabe (Asuri Washi Shiokoki) Net Wt.: 70GR/2.47oz  SKU: 4 971455 081714    Ingredients:  Sardine, Salted Rice Malt, Sugar, Sorbitol, Monosodium Glutamate    Keep Refrigerated    Exported By: KC Central Trading Co. Ltd.  4F 7-2 Irifune 3-Chome Chuo-Ku  Tokyo 104-0042 Japan 03-3552-6906
Mitsuwa Corporation is initiating a recall of Baked Seasoned Sardine Okabe (Asuri Washi Shiokoki), Baked Seasoned Sardine Ambient Okabe (Iwashi Senbei), and Baked Seasoned Goby Okabe (Osakana Roll) due to not refrigerating the products when labeled to be kept refrigerated.
Baked Seasoned Sardine Ambient Okabe (Iwashi Senbei) Net Wt.: 77GR/2.65oz      Ingredients:  Sardines, Sugar, Milk Protein Hydrolysate, Soy Sauce (Water, Soybean, Wheat, Salt), Sweet Cooking Wine, Sesame, Red Pepper, Monosodium Glutamate    Keep Refrigerated  Product of Japan    Exported By: KC Central Trading Co. Ltd.  4F 7-2 Irifune 3-Chome Chuo-Ku  Tokyo 104-0042 Japan 03-3552-6906
Baked Seasoned Goby Okabe (Osakana Roll) Net Wt.: 65GR/2.29oz      Ingredients:  Goby, Sugar, Salt, Sorbitol, Monosodium Glutamate    Keep Refrigerated  SKU: 4 971455 081738  Product of Japan    Exported By: KC Central Trading Co. Ltd.  4F 7-2 Irifune 3-Chome Chuo-Ku  Tokyo 104-0042 Japan 03-3552-6906
CT FL  MA  MD  ME  NC  NH  NJ  NY  OH  PA  TX  VA  VT
Acadia Natural Spring Water, 16.9 Fl Oz, Distributed by FoodHold USA, Inc, Landover, MD 20785;  Acadia Natural Spring Water, 8 Fl Oz, Distributed By: FoodHold USA, LLC, Landover, MD 20785;     Acme Natural Spring Water, 16.9 Fl Oz., Distributed By Supervalu, inc., Eden Prairie, MN 55344;     Blu all natural Spring Water, 16.9 Fl Oz, Distributed by: Millennium Food Group, Locust Valley, NY 11560;     Big Y Spring Water, 16.9 Fl Oz, Distributed by Gig Y Foods, Inc., Springfield, MA 01104;     Best Yet Spring Water, 16.9 Fl Oz, Bottled By: Niagara Bottling, LLC, Ontario, CA 91761;      7 Select Spring Water, Net Wt. 16.9 FL OZ, Distributed By: 7-Eleven, Inc., Dallas, TX 75201;     7 Select Spring Water, 33.8 Fl Oz, Distributed By 7-Eleven, Inc., Dallas  TX 75201;     Morning Fresh Farms Mountain Spring Water, 16.9 Fl Oz, Distributed By Merchants Distributors, LLC, Hickory, NC  28601;     Niagara Natural Spring Water, Net. 8 fl oz, Bottled by Niagara Bottling, LLC, Ontario, CA 91761;   Niagara Natural Spring Water, Net. 16.9 fl oz, Bottled by Niagara bottling, LLC, Ontario, CA 91761;     Nature's Place all natural Spring Water, 8 Fl Oz, Distributed by DZA Brands, LLC, Salisbury, NC 28147/Scarborough, ME 04074;    Nature's Place all natural Spring Water, 16.9 Fl Oz, Distributed by DZA Brands, LLC, Salisbury, NC 28147/Scarborough, ME 04074;       Price Rite Spring Water, 16.9 Fl Oz, Bottled By Niagara Bottling, LLC., Ontario, CA 91761;     Super Chill H2O Natural Spring Water, 16.9 Fl Oz, Distributed By Supervalu Inc., Eden Prairie, MN 55344;     Shaw's Natural Spring Water, 8 Fl Oz, Distributed by Supervalu Inc., Eden Prairie, MN 55344;     Shoprite Spring Water, 16.9 Fl Oz, Distributed By Wakefern Food Corp, Elizabeth, NJ 07207;   Shoprite Spring Water, 8 Fl Oz, Distributed By Wakefern Food Corp, Elizabeth, NJ 07207;       Wegmans Spring Water, 16.9 Fl Oz, Distributed by Wegmans Food Markets, Inc., Rochester, NY 14603;
Hamburg - Case Codes     F2 BEST BY 13DEC2016      F2 BEST BY 14DEC2016      F2 BEST BY 15DEC2016      F2 BEST BY 16DEC2016      F1 BEST BY 16DEC2016            Allentown - Case Codes  A3 BEST BY 09JUN2016 A1 BEST BY 08DEC2016   A1 BEST BY 09DEC2016 A1 BEST BY 10DEC2016   A1 BEST BY 11DEC2016  A3 BEST BY 10JUN2016 A2 BEST BY 08DEC2016   A2 BEST BY 09DEC2016 A2 BEST BY 10DEC2016   A2 BEST BY 11DEC2016  A1 BEST BY 13JUN2016 A3 BEST BY 08DEC2016   A3 BEST BY 09DEC2016 A3 BEST BY 10DEC2016   A3 BEST BY 11DEC2016  A3 BEST BY 15JUN2016 A4 BEST BY 08DEC2016   A4 BEST BY 09DEC2016 A4 BEST BY 10DEC2016   A4 BEST BY 11DEC2016  A3 BEST BY 16JUN2016 A6 BEST BY 08DEC2016   A6 BEST BY 09DEC2016 A6 BEST BY 10DEC2016   A6 BEST BY 11DEC2016  A4 BEST BY 16JUN2016 A7 BEST BY 08DEC2016   A7 BEST BY 09DEC2016 A7 BEST BY 10DEC2016   A7 BEST BY 11DEC2016  A8 BEST BY 08DEC2016 A8 BEST BY 09DEC2016   A8 BEST BY 10DEC2016 A8 BEST BY 11DEC2016      Allentown - Case Codes     A1 BEST BY 12DEC2016 A1 BEST BY 13DEC2016   A1 BEST BY 14DEC2016 A1 BEST BY 15DEC2016   A1 BEST BY 16DEC2016  A2 BEST BY 12DEC2016 A2 BEST BY 13DEC2016   A2 BEST BY 14DEC2016 A2 BEST BY 15DEC2016   A2 BEST BY 16DEC2016  A3 BEST BY 12DEC2016 A3 BEST BY 13DEC2016   A3 BEST BY 14DEC2016 A3 BEST BY 15DEC2016   A3 BEST BY 16DEC2016  A4 BEST BY 12DEC2016 A4 BEST BY 13DEC2016   A4 BEST BY 14DEC2016 A4 BEST BY 15DEC2016   A4 BEST BY 16DEC2016  A6 BEST BY 12DEC2016 A6 BEST BY 13DEC2016   A6 BEST BY 14DEC2016 A6 BEST BY 15DEC2016   A6 BEST BY 16DEC2016  A7 BEST BY 12DEC2016 A7 BEST BY 13DEC2016   A7 BEST BY 14DEC2016 A7 BEST BY 15DEC2016   A7 BEST BY 16DEC2016  A8 BEST BY 12DEC2016 A8 BEST BY 13DEC2016   A8 BEST BY 14DEC2016 A8 BEST BY 15DEC2016   A8 BEST BY 16DEC2016          Best By 08DEC2016 to 16DEC2016    Wegmans only:  A3 Best By 09Jun2016; 10JUN2016; 15JUN2016; 16JUN2016;     A1 Best By 13JUN2016  A4 Best BY 16JUN2016
Source Spring Water was analyzed and found positive for E. coli and total coliform
Blood and Blood Products for Reprocessing
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood product, collected from a donor who received a piercing within one year of donation, was distributed.
Blood product, collected from a donor with a history of incarceration, was distributed.
Blood product, which was tested for residual White Blood Cells using a sample that exceeded acceptable time limits, was distributed.
Human corneas, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, were distributed.
Source Plasma, collected from inelgible donors, was distributed.
Worldwide Distribution - US (nationwide) Distribution including Puerto Rico, and to the states of : AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA  and WI., and to the countries of :  AUSTRALIA, CANDA, FRANCE, NEW ZEALAND, SOUTH AFRICA, TRINIDAD AND TOBAGO
Invacare Pronto Air Personal Transporter (power wheelchair),  Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, (800) 333 -6900.
The batteries used in the Invacare Pronto Air Personal Transporter models power wheelchairs have the possibility to overheat during charging which could potentially result in leaking battery acid and/or swelling battery, loss of use, chemical burns and/or property damage.
Nationwide Distribution, including Puerto Rico and the country of Canada.
PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit.     Latex agglutination test for identification of beta-hemolytic streptococci of Lancefield Groups A, B, C, F or G from primary culture plates.
A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap.     Latex reagent for streptococcal group B; Identify beta-hemolytic streptococci of Lancefield Groups A, B, C, F and G from primary culture plates.
Blood products, in which quality control and distribution of products did not meet specifications, were distributed.
0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation Deerfield, IL 60015,  NDC 0338-0049-03.
Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protectors.
Distribution Japan,  No US distribution.
ReSTOR intraocular lens and ReSTOR Toric intraocular lens.   The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber lenses intended as optical implants designed to replace the human crystalline lens in adult patients following cataract surgery. The lenses subject to this correction are manufactured specifically for Japan.
Model Numbers: SN6AD1, SN6AD3, SV25T0, MN6AD1,SND1T3, SND1T4, SND1T5 and SND1T6 and all lot numbers.
There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery.
Bella Rosa Parmesan Net Wt. 20 oz (567 g) 1.25 LB Arthur Schuman, Inc. Fairfield, NJ 07064  UPC 088231410041
BEL07202BJV2    July 14, 2015, August 8, 2015 and September 11, 2015
Bella Rosa Grated Parmesan Cheese may contain undeclared egg lysozyme.
Wall Chart for STERRAD 100NX System, P/N 10104.   The STERRAD 100NX Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures.
Advanced Sterilization PRoducts (ASP) is recalling the Wall Chart for STERRAD 100NX System because it incorrectly states ''APTIMAX Instrument Trays can be enclosed in either polypropylene wrap or in Tyvek Pouches with STERRAD Chemical Indicators.''
Metabolic Response Modifiers (MRM) is recalling DHEA 25 mg capsules, 60 count and 90 count, because they may contain more DHEA than the label claims.
PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software.  Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000).   Allows physicians to program devices to pace exclusively in the left ventricle.
Ventricular packing: LV software programming versions for  BIOTRONIK CRT-P and CRT-D devices are recalled because they are not approved for use in the US.
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
Blood products, collected using a Hemoflow device for which the quality control results were not documented, were distributed.
Nationwide.  No foreign or VA/govt/military consignees.
Glucosamine 750 mg 120 ct, Capsule, Dosage: 12 capsules, 750 mg ea., three times daily with meals
TSN Labs is conducting a field action on Glucosamine 750 mg 120 ct due to inadequate allergen labeling.
Worldwide Distribution - US (nationwide) and Internationally to China, Lebanon, Costa Rica, Singapore, Brazil, Jordan, Russia, Greece, Austria, India, Nigeria, United Kingdom, Korea, Saudi Arabia, Morocco, Slovenia, Portugal, Tunisia, Kazakhstn, Qatar, U.A.E.  Israel, Taiwan, Mexico, Argentina, Poland, Italy, Hong Kong, Kuwait, Switzerland, Turkey, Ireland, Chile, Germany, and Australia.
i-Stat PT/INR Cartridges List number 03P89-24   The cartridges are packaged in sealed pouches, one per pouch.  There are 24 cartridges packed in a box.  a prothrombin time test useful in monitoring patients receiving oral anticoagulation therapy such as coumadin or warfarin.
All lots from S15007 to S15026 inclusive and All lots from T15037A to T15076A inclusive.
Certain lots of PT/INR cartridges may generate a higher than typical number of PT/INR star outs potentially delaying the generation of patient results for PT/INR.
Celsite Implantable Access Port System, model ST301.  The Celsite Implantable Access Port Systems (Celsite port systems) are implantable port and catheter systems that allow safe, repeated access to the patient's bloodstream.  The port chamber and catheter design can be used for the administration of medication and fluids.  The Celsite system consists of an access port with a silicone septum, which is connected to a catheter using a connection ring.  The triangular shaped access port has a low profile nose, finger stops on the side of the housing, and a round base.  Celsite access ports have suture holes or suture zones to secure placement during implantation.
The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537).
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Aurora Area Blood Bank dba Heartland Blood Centers
Blood product, in which documentation of Apheresis record  was incomplete, was distributed.
Nationwide Foreign Canada, Denmark. Italy
Perfectum Tuberculin Glass Syringe, Non sterile Catalog numbers 5202, 5205, 5212
Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel.
Micro-Mate Tuberculin Glass Syringe, Non-sterile Catalog numbers 5208, 5209
Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm   Product Usage:  The Triathlon PS X3 (posterior stabilized), cat no 5532-G-xxx and X3 TS (total stabilizing) Plus, cat. no. 5537-G-XXX, Tibial Inserts are used in TKA surgeries. During surgery, the tibial insert is locked into the tibial baseplate where it serves as the bearing component for the articulating surface of a corresponding Triathlon femoral component.
Catalog Number 5532-G-511 Lot LD8D7Y    Catalog Number 5537-G-319  Lot TT6JT2
Stryker Orthopaedics received a report that 5537-G-319 No 3. Triathlon TS Plus Tibial Insert X3 Poly 19 mm i insert was in a package labeled as a 5532-G-511 Triathlon PS Stibialism Insert.
Nationwide Distribution including the Virgin Islands.
ReSolve Locking Drainage Catheters   The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.
Merit Medical Systems, Inc. is voluntarily conducting a recall due to a potential discrepancy between the unit labeling of the Merit ReSolve Drainage Catheters and the actual device in the package.
LV Foods, Incorporated dba Lee Egg Rolls
Lee Egg Rolls Vegetables and Textured Vegetable Protein, Net Wt. 15lbs. 0 oz., Lee Egg Rolls Jacinto City, Texas 77029
Product is sold exclusively in Hy-Vee retail grocery stores in Iowa, Illinois, Kansas, Minnesota, Missouri, Nebraska, South Dakota and Wisconsin.
Dijon Mustard Potato Salad, NET WT 3 LB (1.36 kg)
Lot Code: 15177D, Best if Used By: JUL. 31, 2015
Cups of macaroni salad are in tubs which declare the product to be potato salad and fail to disclose the presence of milk and wheat allergens.
Nationwide Distribution including FL, AZ, and CA.
Etac Relax wall mounted shower seat The Etac Relax is a wall mounted shower seat designed as a seating and standing support for personal hygiene purposes for people with reduced mobility. The Etac Relax shower seat is used for sitting where space is restricted, and can be folded up when not in use. Etac Relax is intended for home use.
The affected products are individually identified within the serial number range: 1-425 regarding Art No. 81703030, 1-205 regarding Art No. 81703050, All distributed regarding Art No. 81703080
The recalling firm has received reports of a malfunction of the Relax wall mounted shower seat where the wall bracket has cracked or broken.
Worldwide Distribution-US (nationwide) including Puerto Rico, and the countries of  Angola, Antilles, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Belgium, Bulgaria, Bahrain, Brasilia, Belarus, Canada, Switzerland, Chile, China, Columbia, Cyprus, Czech Republic, Germany, Denmark, Algerian, Ecuador, Estonia, Egypt, Spain, Finland, France, Gabon, United Kingdom, Georgian Republic, Greece, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iraq, Iran, Iceland, Italy, Jordan, Japan, Kenya, South Korea, Kuwait, Kazakhstan, Lebanon, Liechtenstein, Lithuania, Luxembourg, Latvia, Libya, Morocco, Macedonia, Myanmar/Burma, Malta, Mauritius, Mexico, Malaysia, Netherlands, Norway, New Zealand, Peru, Philippines, Pakistan, Poland, Palestine, Portugal, Qatar, Romania, Russia, Saudi Arabia, Sudan, Sweden, Singapore, Slovenia, Slovakia, San Marino, Syria, Thailand, Turkmenistan, Tunisia, Turkey, Taiwan, Ukraine, United Arabian Emirates, Uruguay, Venezuela, British Virgin Islands, Vietnam, Kosovo, Serbia and South Africa.*
Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932.   The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
The following Material numbers may appear on any of the attached recalled/corrected units: Material #0376288, Description: Federarm 3kg, 3 polig (Swing); 0376289, Federarm 12-18kg, 5-polig Kamera eco; 0376290, Federarm TFT Stop AC 2000, 9-15kg; 0376291, Federarm TFT Stop AC 3000, 12-18kg; 0376292, Federarm TFT Stop Space bis 30kg; 0376293, Federarm 3-polig NRH; 0376294, Federarm 5-polig NRH; 0376295, Federarm 3-polig NRH gerader Abgang; 0376296, Federarm 5-polig NRH gerader Abgang; 0379528, FA AC3000, Stop 7-11KG; 0385719, FA AC 2000 NRH mobil 3p, 12-18kg NG; 1387323, Federarmsicherungssegment AC3000; 1387324, Federarmsicherungssegment AC2000; 1388338, Federarm 12-18 kg 3 polig, HEL2; 1388339, Federarm 12-18 kg 5 polig HEL2; 1388340, Federarm 12-18 kg 9 polig (HELION); 1408906, FA AC2 Stop max 11kg; 1471010, FA AC2000 3p, 12-18kg; 1471011, FA AC2000 Stop 12-18kg; 1471012, FA AC2000 NRH 3p, 12-18kg; 1471013, FA AC2000, 7p, 12-18kg; 1471014, FA AC2000 NRH 7p, 12-18kg; 1471015, FA AC3000 3p, 23-30kg; 1471016, FA AC2000 Stop 6-11kg; 1471017, FA AC2000 TruVidia 7p, 3,5-7kg; 1471018, FA AC2000 Stop 3,5-7kg; 1471351, FA AC3000 NRH 3p, 23-30kg; 1502084, FA AC2 NRH fr HEL2, 3POL.; 1504731, Federarm 9-POLIG NRH HEL2; 1507085, (R)FEDERARM AC2000; 1645860, FA AC 2000 NRH mobil 7p, 12-18kg NG; 1645861, FA AC 2000 NRH 7p, 12-18kg NG; 1649687, FA AC 2000 SlimLine STOP, 12-18kg; 1649872, FA AC 2000 SlimLine 3p, 12-18kg; 1649997, Deckenrohr 2f Slimline 1000; 1774143, Ausleger AC2000, 750mm, 3p; 1982310, FA AC2000 MAVIG Protegra2 6-11kg; 1982311, FA AC2000 MAVIG Protegra2 12-18kg; 1982312, FA AC2000 3p, 13,5-21kg; 1982313, FA AC2000 NRH 3p, 13,5-21kg; 4024211, Federarm AC2000; 4024212, FA AC2 Stop; 4024213, FA AC3; 4024214, FA AC3000 Stop, 12-18kg; 4024215, FA AC5000 Stop; 4024651, FA AC3000, 7p; 4024652, FA AC2 3K; 024848, Federarm AC3000 NRH; 4025574, FA AC3000 Stop 23-30 kg; 4025575, FA AC5000 Stop max 15 kg; 4025576, FA AC2 K TruVidia; 8800900, Federarm HELION L+ 12,5 kg 5-polig; 8800901, Federarm HELION M+ 12,5 kg 3-polig;
Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Manual #1528403.   The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual #1441784.   The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia SD, User Manual #1400191.   The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia HD, User Manual #1513140.   The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid)  Product Code: 08-4000-LB
Lots begin with: 15AMLB, 15BMLB, 15CMLB.
Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination.
8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
The possibility exists for intraoperative reamer head breakages which could also allow for un-retrieved fragments of non-implant grade material: additional lot numbers identified. No new adverse events reported.
Pride of Africa brand Enriched Farina, Net Weight 5 lb. (2.27 kg), UPC 016712016840 --- Product of The Raymond-Hadley Corp. Spencer, NY 14883 --- Product is packaged in a clear plastic pouch with green, brown and white artwork.
200 cases (6 x 5 lbs. packages per case)
Pride of Africa Enriched Farina label failed to declare the presence of wheat.
FITzee Foods Paleo Turkey Meatloaf all sizes (small, medium, large and XL)
all sizes; from: June 20, 2015 through July 16, 2015.
Optimal Nutrition dba FITzee Foods is recalling Paleo Meatloaf because it contains green beans which is on recall due to Listeria monocytogenes.
biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0488-01
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original, a) 0.70 oz (19.8 g) tubes., (NDC 0135-0557-02) , b) 0.75 oz. (21.3 g) tubes, (NDC 0135-0487-02), c) 4.3 oz. (121.9 g) tubes, (NDC 0135-0557-01), d) 4.5 oz. (127.6 g) tubes, (NDC 0135-0487-01), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108
biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tubes, Manufactured by Oratech, South Jordan, UTAH, 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108 NDC 0135-0558-01
biotene PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. (121.9 g) tubes, (NDC 0135-0559-01), biotene PBF Paste, b) 4.5 oz.(127.6 g) tubes, (NDC 0135-0490-02), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108
SENSODYNE EXTRA FRESH COMPLETE PROTECTION, 3.4 oz.(96.4 g) tubes, Manufactured by Oratech, South Jordan UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0572-02
SENSODYNE COMPLETE PROTECTION, 3.4 oz. (96.4 g)tubes, Manufactured by Oratech, South Jordan UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108,  NDC 0135-0573-02
SENSODYNE EXTRA FRESH REPAIR & PROTECT, 3.4 oz. (96.4 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108,  NDC 0135-0547-02
SENSODYNE WITH FLUORIDE REPAIR & PROTECT, a) 0.8 oz.(23 g) tubes, (NDC 0135-0548-01);  b) 3.4 oz. (96.4 g) tubes, (NDC 0135-0548-02) Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108
Product was shipped to the following state: OH.
Janka Fully Cooked Apricot Pierogi Ingredients: DOUGH: Blended Flour (Wheat Flour, Malted Barley Flour, Niacin, Iron, Potassium Bromate, Thiamine Mononitrate, Riboflavin), Water, Whole Milk, Eggs, Dried Potatoes (Color and Flavor Protected with Sodium Bisulfate, Citric Acid and BHT), Oleomargarine (Liquid Soybean Oil, Partially Hydrogenated Soybean Oil, Water, Salt, Vegetable Lecithin, Vegetable Mono and Diglycerides, Whey Citric Acid, Calcium Disodium EDTA and Sodium Benzoate as preservatives. Artificially Flavored, Colored with Carotene, Vitamin A Palmitate Added), Salt, Sugar.  FILLING: Sugar Syrup, Apricots prepared with Sulphur, Corn Syrup, Vegetable Stabilizer.  FD & C Yellow #6.
Food recall due to misbranding/incorrect labeling of Janka Apricot Pierogies.  Yellow #5 not included on label of final product.
JAMES FARM GARDEN PEAS CHICHAROS, NET Wt. 40 OZ (2.5 LBS), FRESH FROZEN, UPC 7 60695 01000, product is packed in plastic bags and shipped as 12 units/40 oz. per carton, Net Wt. 30lb.  Distributed by RD/Jet, LLC 15-24 132 nd Street College Point, NY 11356.  PRODUCT OF POLAND.
Jetro Restaurant Depot has initiated a recall due to Listeria monocytogenes contamination.
OK, IL, FL, AZ, KS, OH, CA, AL, KY, TX, OR, MS, NJ, MA, WA, TN, MI, MN, UT, VA, NC, GA, PA, MO, NY, WI, NH, AK, CO, NE and Hawaii
Coenzyme Q-10 50 mg label reads in part, ''***Major***CO Q-10 50 MG***For healthy HEART & IMMUNE function***Promotes ENERGY in all Body Cells***Dietary Supplement 30 SOFTGELS***.''
Product codes 700220/ 4211-30 Lot number 14378T, expiration date 08/2017.
Product is mislabeled.  Some of the Co Q 10 30 mg bottles were labeled with the incorrect label, Co Q 10 50 mg.
Aurora Area Blood Bank Dba Heartland Blood Centers
Blood product, incorrectly labeled as negative for the Jka red cell antigen, was distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN TX, UT, VT, VA, WA, WV, WI & DC
Grizzly Premium Mint Long Cut, Moist Snuff, Manufactured By: American Snuff Company, LLC, Memphis, TN, 5 - 1.2 oz. (34.02 g) cans Net Wt. 6 oz (170.1 g), UPC 0 429101 1, SKU(s) 2101910000; 7501010002
Potential presence of foreign material (plastic) inside the products. These products may contain one or more pieces of plastic that chipped off of the top edge of the moist snuff cans during the manufacturing process. The plastic pieces may be sharp and large enough to pose a potential health hazard to users of the products.
Grizzly Premium Straight Long Cut, Moist Snuff, Manufactured By: American Snuff Company, LLC, Memphis, TN, 5 - 1.2 oz. (34.02 g) cans Net Wt. 6 oz (170.1 g), UPC 0 428861 9, SKU(s) 2101886000; 7501886002
Grizzly Premium Wintergreen Long Cut, Moist Snuff, Manufactured By: American Snuff Company, LLC, Memphis, TN, 5 - 1.2 oz. (34.02 g) cans Net Wt. 6 oz (170.1 g), UPC 0 428711 5, SKU 2101871000
Kodiak Premium Wintergreen, Moist Snuff, Manufactured By: American Snuff Company, LLC, Memphis, TN, 5 - 1.2 oz. (34.02 g) cans Net Wt. 6 oz (170.1 g), UPC 0 422941 2, SKU(s) 2101234000; 7501234002
AMERICA'S BEST CORRIANDER POWDER, NET WT.: 1) 7 OZ, 2) 14 OZ. (400 GMS) and 3) 28 OZ, sealed in plastic bags, Packed by Patel Grocery 5303 4th Ave. Brooklyn, NY 11220
The product was found to contain undeclared peanut allergens based on sampling and analysis by New York State Department of Agriculture & Markets.
Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius Kabi USA 2020 N Ruby Street, Melrose Park, IL 60160-1112 for Fresenius Kabi USA, 3 Corporate Dr Lake Zurich, IL 60047-8930. NDC 63323-614-01
Incorrect Expiration Date: The ''11/06'' expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)
Worldwide Distribution - US including AZ, MO, OH and Internationally to GERMANY and SPAIN.
AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553, Sterilized Using Ethylene Oxide. The AngioJet Spiroflex Thrombectomy Set is intended for: '' Breaking apart and removing thrombus from infra-inguinal peripheral arteries e 2.0 mm in diameter. '' Removing thrombus in the treatment of patients with symptomatic coronary artery or saphenous vein graft lesions in vessels e 2.0mm in diameter prior to balloon angioplasty or stent placement. The AngioJet SOLENT'' Omni Thrombectomy Set is intended for: '' Breaking apart and removing thrombus from upper and lower extremity peripheral arteries e 3.0mm in diameter, upper extremity peripheral veins e 3.0mm in diameter, ileofemoral and lower extremity veins e 3.0mm in diameter, and A-V access conduits e 3.0mm in diameter. '' Use with the AngioJet Ultra Power Pulse technique for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system. The AngioJet SOLENT'' Dista Thrombectomy Set is intended for: '' Breaking apart and removing thrombus from upper and lower extremity peripheral arteries > 1.5 mm '' Use with the AngioJet Ultra Power Pulse technique for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system. The AngioJet AVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits e 3.0 mm in diameter.
AngioJet products were distributed with an incorrect use-by (expiry) date.  The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015.
AngioJet SOLENT'' Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681,  Sterilized Using Ethylene Oxide. The AngioJet Spiroflex Thrombectomy Set is intended for: '' Breaking apart and removing thrombus from infra-inguinal peripheral arteries e 2.0 mm in diameter. '' Removing thrombus in the treatment of patients with symptomatic coronary artery or saphenous vein graft lesions in vessels e 2.0mm in diameter prior to balloon angioplasty or stent placement. The AngioJet SOLENT'' Omni Thrombectomy Set is intended for: '' Breaking apart and removing thrombus from upper and lower extremity peripheral arteries e 3.0mm in diameter, upper extremity peripheral veins e 3.0mm in diameter, ileofemoral and lower extremity veins e 3.0mm in diameter, and A-V access conduits e 3.0mm in diameter. '' Use with the AngioJet Ultra Power Pulse technique for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system. The AngioJet SOLENT'' Dista Thrombectomy Set is intended for: '' Breaking apart and removing thrombus from upper and lower extremity peripheral arteries > 1.5 mm '' Use with the AngioJet Ultra Power Pulse technique for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system. The AngioJet AVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits e 3.0 mm in diameter.
AngioJet SOLENT'' Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized Using Ethylene Oxide. The AngioJet Spiroflex Thrombectomy Set is intended for: '' Breaking apart and removing thrombus from infra-inguinal peripheral arteries e 2.0 mm in diameter. '' Removing thrombus in the treatment of patients with symptomatic coronary artery or saphenous vein graft lesions in vessels e 2.0mm in diameter prior to balloon angioplasty or stent placement. The AngioJet SOLENT'' Omni Thrombectomy Set is intended for: '' Breaking apart and removing thrombus from upper and lower extremity peripheral arteries e 3.0mm in diameter, upper extremity peripheral veins e 3.0mm in diameter, ileofemoral and lower extremity veins e 3.0mm in diameter, and A-V access conduits e 3.0mm in diameter. '' Use with the AngioJet Ultra Power Pulse technique for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system. The AngioJet SOLENT'' Dista Thrombectomy Set is intended for: '' Breaking apart and removing thrombus from upper and lower extremity peripheral arteries > 1.5 mm '' Use with the AngioJet Ultra Power Pulse technique for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system. The AngioJet AVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits e 3.0 mm in diameter.
AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized Using Ethylene Oxide.   The AngioJet Spiroflex Thrombectomy Set is intended for: '' Breaking apart and removing thrombus from infra-inguinal peripheral arteries e 2.0 mm in diameter. '' Removing thrombus in the treatment of patients with symptomatic coronary artery or saphenous vein graft lesions in vessels e 2.0mm in diameter prior to balloon angioplasty or stent placement. The AngioJet SOLENT'' Omni Thrombectomy Set is intended for: '' Breaking apart and removing thrombus from upper and lower extremity peripheral arteries e 3.0mm in diameter, upper extremity peripheral veins e 3.0mm in diameter, ileofemoral and lower extremity veins e 3.0mm in diameter, and A-V access conduits e 3.0mm in diameter. '' Use with the AngioJet Ultra Power Pulse technique for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system. The AngioJet SOLENT'' Dista Thrombectomy Set is intended for: '' Breaking apart and removing thrombus from upper and lower extremity peripheral arteries > 1.5 mm '' Use with the AngioJet Ultra Power Pulse technique for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system. The AngioJet AVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits e 3.0 mm in diameter.
Product was distrubuted multiple whole sale stores throughout the country. A list of all stores has been attached and sent via email to CFSAN recalls.
Kraft American Singles Pasteurized prepared cheese products packaged clear plastic. Sold at retail as 1 lb. packages. Some products are only packaged in the clear plastic and some are packaged in the clear plastic with a blue label attached with white, black, and blue lettering.
Code dates: December 29, 2015 to January 4, 2016 UPC codes for the cases: 210006255900 and 210006152400  UPC code for the units: 0 2100063360 9 and 0 2100060491 3
1,1648 cases of the 4 lb. packages (4- 1 lb. packages/case) and 17,177 cases of the 3 lb. package.(3-1 lb. packages/case).
The Kraft American Singles Pasteurized prepared cheese products contain a thin strip of plastic film that may remain on the edge of some cheese slices after the wrapper is removed.
Kraft American Singles white American Pasteurized prepared cheese products packaged clear plastic. Sold at retail as 1lb. packages. Some products are only packaged in the clear plastic and some are packaged in the clear plastic with a blue label attached with white, black, and blue lettering.
Code dates: December 29, 2015 to January 4, 2016 UPC code for the 3 lb. case: 210006154700  UPC code for the 4 lb. case: 210006256000  UPC code for the 3 lb. packages: 0 2100061582 7  UPC code for the 4 lb. packages: 0 2100063448 4
3,245 cases of the 3 lb. packages (3-1 lb. packages/case) and 3,689 cases of the 4 lb. packages(4-1 lb. package/case).
Human cornea, that did not meet release criteria, was distributed.
Rivastigmine Tartrate Capsules, USP 1.5 mg, 60 count bottle, Rx Only, Mfd. By Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-352-60
Failed Dissolution Specifications: Out-of-specification results for dissolution found.