• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of May 13, 2015

  • Print
  • Share
  • E-mail
-
Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Drugs Forever Beautiful INFINITY, capsules, 300mg in 60-count bottles, 900 Commonwealth Place, Ste 104, Virginia Beach, VA UPC CODE: 633090804649 Exp unknown Class I Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein REFA Enterprises, LLC
Drugs Forever Beautiful BEE POLLEN, capsules, 250mg in 60-count bottles, 900 Commonwealth Place, Ste 104, Virginia Beach, VA UPC CODE: 633090804632, Exp unknown Class I Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein REFA Enterprises, LLC
Drugs M1-ALPHA LABS MEGA MASS BUILDER (M1A, Methyl-1-Etiocholenolol- 20mg, Epietiocholanolone) Capsules, 60 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789 All lots Class I Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs. Anabolic Science Labs, LLC
Drugs M14-MENT ADVANCED MASS BUILDER (7a-Methyl-estra-4-en-3,17-dione MENT 5mg, M14D 20 mg), Capsules, 90 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789 All lots Class I Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs. Anabolic Science Labs, LLC
Drugs HALO-70 MEGA MASS BUILDER (4-chloro-17a-methyl-androst-1,4-diene-3b,17b-diol 35mg), Capsules, 60 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789 All lots Class I Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs. Anabolic Science Labs, LLC
Drugs 7-MENT ALPHA ADVANCED MASS BUILDER (7a-methyl-estra-4-en-3,17-dione 10 mg), Capsules, 90 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789 All lots Class I Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs. Anabolic Science Labs, LLC
Drugs ESTRASTAIN PRO-ANABOLIC MASS AND HARDENING COMPLEX (Estra-4,9,11-triene-3,17-dione 15mg, 2a-3a-epithio-17a-methyl-5a-androstan-17b-ol 10 mg), Capsules, 60 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789 All lots Class I Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs. Anabolic Science Labs, LLC
Drugs SWOLL-250 SUPER MASS BUILDER QUAD STACK (18-Methylestr-4-en-3-one-17b-ol 15mg, 6-a-Chloro-androst-4-en-17b-ol-3-one 15mg, 13-ethyl-3-methoxy-gona-2,5(10)-diene-17-one 15mg, 2,17a-dimethyl-5a-androsta-1-en-17b-ol-3-one 3 mg), Capsules, 90 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789 All lots Class I Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs. Anabolic Science Labs, LLC
Drugs PROFESSIONAL FORMEXX BLACK (AromaMaXX 250mg: 13-dimethyl-1,2,7,8,9,11,12,14,15,16-decahydro-cyclopenta[a]phenanthrene-3,6,17-trione,4-Androsten 4,17-beta-diol-3one), Capsules, 60 count bottle, Manufactured for: ANABOLIC SCIENCE LABS WINTER PARK, FL 32789 All lots Class I Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs. Anabolic Science Labs, LLC
Food Pride of Szeged Hungarian Exquisite 100 % Sweet Delicacy Paprika, Net Wt. 5 oz., 142g, UPC 0 78006 00010 2 Lot # 091617PAHU05PS Lot # 091717PAHU05PS Class I Spiceco is recalling Pride of Szeged Sweet Hungarian Paprika because it may contain undeclared peanut protein. Spiceco expanded their recall to include additional products that contain the implicated paprika. Spiceco, Inc.
Food Emeril's Cajun Seasoning Blend, 3.45 oz. (98g) Distributed by: B&G Foods, Inc., Parsippany, NJ 07054 USA, UPC 07468309979 Code Nos. 082017, 082117, 092217 and 120817 Class II Spiceco is recalling Pride of Szeged Sweet Hungarian Paprika because it may contain undeclared peanut protein. Spiceco expanded their recall to include additional products that contain the implicated paprika. Spiceco, Inc.
Food Emeril's Blackened Seasoning Blend, 3.1 oz. (88g) Distributed by: B&G Foods, Inc., Parsippany, NJ 07054 USA, UPC 074683097633 Best By Dates: Aug. 22, 2017, Aug. 25, 2017 and Dec. 09, 2017 Class II Spiceco is recalling Pride of Szeged Sweet Hungarian Paprika because it may contain undeclared peanut protein. Spiceco expanded their recall to include additional products that contain the implicated paprika. Spiceco, Inc.
Food Sylvia's Rib Rub N More Seasoning, Net Wt. 5.5 oz. (155g), Distributed by: Sylvia Woods Food Company, P.O. Box 240, Harlem, NY 10027, UPC 608623000683 Best by 12 31 17 Class II Spiceco is recalling Pride of Szeged Sweet Hungarian Paprika because it may contain undeclared peanut protein. Spiceco expanded their recall to include additional products that contain the implicated paprika. Spiceco, Inc.
Food Sylvia's Sizzlin' Hot Spice, Net Wt. 5.5 oz. (156g), Distributed by: Sylvia Woods Food Company, P.O. Box 240, Harlem, NY 10027, UPC 608623000515 Code #'s 092217HHSBX and 092317HHSBX Class II Spiceco is recalling Pride of Szeged Sweet Hungarian Paprika because it may contain undeclared peanut protein. Spiceco expanded their recall to include additional products that contain the implicated paprika. Spiceco, Inc.
Food Shoppers Value Chicken Seasoning 5 oz. - UPC 041130310676 Distributed By: Supervalu Inc., Eden Prairie, MN 55344 USA, Code #'s 081817 and 081917 Class II Spiceco is recalling Pride of Szeged Sweet Hungarian Paprika because it may contain undeclared peanut protein. Spiceco expanded their recall to include additional products that contain the implicated paprika. Spiceco, Inc.
Food Fiesta Seasoned Salt Net Wt 16 oz (1 LB) 454 g Distributed By Fiesta Mart Houston TX 77246-7481 Lot #012218SESA16NL Lot #191617SESA16NL Class II Spiceco is recalling Pride of Szeged Sweet Hungarian Paprika because it may contain undeclared peanut protein. Spiceco expanded their recall to include additional products that contain the implicated paprika. Spiceco, Inc.
Food Spice Eagle Brand Seasoning Salt BLN101200 Net Wt: 50 Lbs Packed by : Spiceco Avenel, New Jersey 07001 Lot #090417SSPBX Class II Spiceco is recalling Pride of Szeged Sweet Hungarian Paprika because it may contain undeclared peanut protein. Spiceco expanded their recall to include additional products that contain the implicated paprika. Spiceco, Inc.
Food Hytop Seasoned Salt Packed for Federated Group, Inc Arlington Heights, IL 60005 a) 5.25 oz. (149 g) UPC 050700083964 b) 16 oz(454 g) UPC 050700482576 Lot #111117SESA67HT; Lot #091617SESA16NL Class II Spiceco is recalling Pride of Szeged Sweet Hungarian Paprika because it may contain undeclared peanut protein. Spiceco expanded their recall to include additional products that contain the implicated paprika. Spiceco, Inc.
Food Spiceco - unlabeled containers of seasoned salt. a) 1 lb. b) 25 lb Lot #011217SESABXNL Lot #100617SESA16NL Lot #100617SESA16NL Lot #100617SESA16NL Lot #100617SESA16NL Class II Spiceco is recalling Pride of Szeged Sweet Hungarian Paprika because it may contain undeclared peanut protein. Spiceco expanded their recall to include additional products that contain the implicated paprika. Spiceco, Inc.
Food Redner's Warehouse Markets Spice Rack Chicken Rub 2.75 oz (77 g) Manufactured for Redner's Warehouse Markets #3 Quarry Road, Reading PA 19605 UPC 015984695937 081817 & 081917 Class II Spiceco is recalling Pride of Szeged Sweet Hungarian Paprika because it may contain undeclared peanut protein. Spiceco expanded their recall to include additional products that contain the implicated paprika. Spiceco, Inc.
Food Maison Royal labeled as ordered on request Class II Spiceco is recalling Pride of Szeged Sweet Hungarian Paprika because it may contain undeclared peanut protein. Spiceco expanded their recall to include additional products that contain the implicated paprika. Spiceco, Inc.
Food Spice Deluxe Chicken Seasoning Net Wt. 3.5 oz (99 g) Manufactured by Spiceco Terminal Way Avenel, NJ 07001 USA www.spice-co.com UPC 078006000048 121517 and 121617 Class II Spiceco is recalling Pride of Szeged Sweet Hungarian Paprika because it may contain undeclared peanut protein. Spiceco expanded their recall to include additional products that contain the implicated paprika. Spiceco, Inc.
Food Pride of Szeged Fish Rub Seasoning Net Wt. 5 oz (142 g) Spiceco, Avenel NJ 07001 UPC 078006020018 2.75 oz 50 lb boxes Lot #092317FIRU05PS; Lot #112017FIRU05PPs; Lot #102117FIRU70TT; Lot #010218FIRU05PPS; Lot #123114; Lot 092214FREBX Class II Spiceco is recalling Pride of Szeged Sweet Hungarian Paprika because it may contain undeclared peanut protein. Spiceco expanded their recall to include additional products that contain the implicated paprika. Spiceco, Inc.
Food Twin Tree Gardens Premium Spice Blends Seasoning Salt Net 5.5 oz (155 g) Distributed to Flavor Delite, Inc. Reinburg South Carolina PC4016 Lot#102214SESA70TT Class II Spiceco is recalling Pride of Szeged Sweet Hungarian Paprika because it may contain undeclared peanut protein. Spiceco expanded their recall to include additional products that contain the implicated paprika. Spiceco, Inc.
Food Better Valu Chicken Seasoning Net. Wt. 5.25 oz (149 g) Distributed by: Federated Group, Inc. 3025 W. Salt Creek Lane Arlington Heights, IL 6005 www.better-valu.com UPC 079807003794 Lot# 081817 Class II Spiceco is recalling Pride of Szeged Sweet Hungarian Paprika because it may contain undeclared peanut protein. Spiceco expanded their recall to include additional products that contain the implicated paprika. Spiceco, Inc.
Drugs EDGE Amplified Weight Release capsules, 400 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00417 4. Lots: ALL Class I Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making EDGE an unapproved drug. Detox Transforms
Drugs iNDiGO capsules, 220 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00404 4. Lot: 000034, Exp 04/10/17 Class I Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making iNDiGO an unapproved drug. Detox Transforms
Drugs AMPD GOLD Bee Pollen capsules, 350 mg, 60-count bottle, Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00418 1. Lots: ALL Class I Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, making AMPD GOLD an unapproved drug. Detox Transforms
Drugs BtRiM Max capsules, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00406 8. Lot: 00002, Exp 04/27/17 Class I Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making BtRiM Max an unapproved drug. Detox Transforms
Drugs iNSANE Bee Pollen capsules, 200 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00408 2. Lot: 0000:02, Exp 06/20/17 Class I Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making iNSANE an unapproved drug. Detox Transforms
Food Ground Cumin, Bulk Package Size: a) 50 lb. paper carton b) 16 oz. jar/ 8 plastic jars per case Lot# 72079, 72596, 72079 Class I Ground cumin may contain peanut protein. International Foodsource, LLC
Food Clear Choice Diet Orange Mango UPC# 061500005582, Net weight 1L All codes Class II May contain a trace amount of Tree Nuts (walnut) which is not listed in the ingredient list Cott Beverages Inc.
Food Red Rain Energy Drink Tropical Mango UPC(250 ml): 0-61500-11806-0, UPC(4 pack x 250 ml): 0-61500-11807-7, UPC(6 x 4 pack x 250 ml): 0-61500-11808-4, UPC(24 x 250 ml): 0-61500-11809-1; ALL LOT CODE DATES Class II May contain a trace amount of Tree Nuts (walnut) which is not listed in the ingredient list Cott Beverages Inc.
Food Inked Mango Energy Drink UPC(473 ml): 0-61500-12211-1, UPC(12 x 473 ml): 0-61500-12212-8; ALL LOT CODE DATES Class II May contain a trace amount of Tree Nuts (walnut) which is not listed in the ingredient list Cott Beverages Inc.
Food Sunny Select Mango Guava UPC 7-17544-11799-5, Net Weight 1 L (12 singles p/c) Class II May contain a trace amount of Tree Nuts (walnut) which is not listed in the ingredient list Cott Beverages Inc.
Food Uforce R140 Tropical Mango Energy Drink UPC 39759339987 16 oz cans (24 p/c) Class II May contain a trace amount of Tree Nuts (walnut) which is not listed in the ingredient list Cott Beverages Inc.
Food Uforce Q40 Tropical Mango Energy Drink UPC 39759339987 16 oz cans (24 p/c) Class II May contain a trace amount of Tree Nuts (walnut) which is not listed in the ingredient list Cott Beverages Inc.
Food Kroger Shots Tropical Mango Flavor UPC 10041260356923 4 x 12, 2 oz. cans (24 p/c) Class II May contain a trace amount of Tree Nuts (walnut) which is not listed in the ingredient list Cott Beverages Inc.
Food Kroger Shots Tropical Mango Flavor 2 pack UPCs: 0 41260 35692 6, 10041260367899 2 pack (48 p/c) Class II May contain a trace amount of Tree Nuts (walnut) which is not listed in the ingredient list Cott Beverages Inc.
Food Rey Panama Tropical Mango UPC 7 453009 201092 1 L, 12 singles p/c Class II May contain a trace amount of Tree Nuts (walnut) which is not listed in the ingredient list Cott Beverages Inc.
Food Clear Splash Orange Mango UPC 6 88267 13672 6 1 L, 12 singles p/c Class II May contain a trace amount of Tree Nuts (walnut) which is not listed in the ingredient list Cott Beverages Inc.
Food Quick Strike Tropical Mango UPC- 0 61500 00527 8 16 oz cans (24 p/c) Class II May contain a trace amount of Tree Nuts (walnut) which is not listed in the ingredient list Cott Beverages Inc.
Devices MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1) Serial Numbers: 201902, 201903, 202903, 202905, 203901, 203902, 203903, 203905, 203906, 203919 & 203924 Class II The operator console allows users to deliver therapeutic radiation to patients even though a specific communication error relevant to imaging conditions has occurred. In addition, the treatment record (the delivered radiation record) cannot be saved. MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
Drugs ULTRA ZX DIETARY SUPPLEMENT (Extracto de Naranjo Amargo 70, Extracto de semilla de Sen 47.6, Lagrima de Coix 42, Almidon Medico 84), 30 capsule bottles, Manufactured and distributed by: Ultra ZX Labs, L.L.C. 2525 SW 3rd Ave Apt 1704 Miami, Florida 33129-2068. All lots/codes/bottles/packages. Class I Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein Ultra ZX Supplements
Devices GE Discovery MR950 MRI system Model Number - Discovery MR950 Class II The alignment lasers are missing the labels required by radiation safety regulations. GE Healthcare
Drugs Epel 18 mg Estradiol Pellet, For In Office Use Only, For In Office Administration Only, Not for Resale or Dispensing to an Individual Patient, Rx Only, Preferred Physician Medical LLC, 405-551-8216 Lot # 06241401-070714Q, Exp 12/14 Class I Non-Sterility: The recalled lot failed sterility testing. Physician Preferred Medical, LLC
Biologics Cryoprecipitated AHF, Pooled W041014116776G Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. United Blood Services
Biologics Blood and Blood Products for Reprocessing W041014116776G Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. United Blood Services
Biologics Red Blood Cells Leukocytes Reduced W051715604812 Class II Blood product, which tested positive for red cell antibodies was not labeled for the red cell antibodies, was distributed. Rhode Island Blood Center
Biologics Red Blood Cells Leukocytes Reduced W038314101127 Class II Blood products, collected from a donor with high risk behavior(s), were distributed. Mississippi Valley Reg Bld Ctr
Biologics Plasma Frozen within 24 hours (FP24) W038314101127 Class II Blood products, collected from a donor with high risk behavior(s), were distributed. Mississippi Valley Reg Bld Ctr
Devices EOS, Digital radiography system used in general radiographic examinations. Model Number - EOS System Class II When performing calibration, an alert message on the spectral filtration of the X-ray beam may be suppressed. Improper filtration of the X-ray Beam can then occur in exams set up with copper filtration. Eos Imaging Inc
Drugs Captopril Tablets, USP 12.5 mg, Rx Only, a) 100 count bottles NDC 64679-902-01, b) 1000 count bottles NDC 64679-902-02, Manufactured by Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt USA LLC., 20 Waterview Boulevard, Parsippany, NJ 07054 USA Lot #s: a) LM10525, Exp 03/15; LM10727, Exp 04/15; LM11519, Exp 08/15; LN10008, Exp 11/15; LN10121, Exp 12/15; LN10887, Exp 04/16; LM11248, Exp 06/16 Lot #s: b) LM10522, Exp 03/15; LM10726, Exp 04/15; LN10007, Exp 11/15; LN10116, Exp 12/15; LN10888, Exp 04/16; LN11281 Exp 07/16 Class II Failed Tablet/Capsule Specifications: out of specification for thickness. Wockhardt Usa Inc.
Food Sazon Coriander & Annatto 72 / 3.52 oz - UPC 4133103772, Display Unit is 3779, Lots: 401095, 401105, 401125, 401135 33 / 36  ...
More
Class II Cumin used was contaminated with peanut protein. Sazon, Inc.
Food Sazon with Saffron, Package Weights: 18 / 20 env 3.52 oz and 36 / 8 env 1.41 oz 18 / 20 env 3.52 oz - UPC 4133103777, Lots: 501095, 501105, 501125, 501145, 501155, 501165, 501175, 501195, and 501205 36 / 8 env 1.41 oz - UPC 4133103784, Lots: 101105, 101125, 101135 and 101145. Class II Cumin used was contaminated with peanut protein. Sazon, Inc.
Food Sazon without Annatto UPC 4133103781, Lots: 301105 and 301125, 24 / 12 env 2.11 oz. Class II Cumin used was contaminated with peanut protein. Sazon, Inc.
Food Sazon Coriander & Annatto Low Sodium UPC 4133103790, Lots: 401095, 401105, 401125 and 401135, 18 / 3.52 oz. Class II Cumin contains undeclared peanut protein. Sazon, Inc.
Food Sazon Bohio with Coriander and Annatto UPC 7639820011, Lots: 601095 and 601105, 6.33 oz. Class II Cumin used has undeclared peanut protein. Sazon, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W036815033032; W036815033032; Class III Blood products, which did not meet the acceptable product specifications, were distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced W053314508646 Class II Blood product, collected from a donor who traveled to a malarial endemic area, was distributed. Community Blood Center, Inc.
Biologics Red Blood Cells W286814018598 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. LifeSource
Biologics Cryoprecipitated AHF, Pooled W286814018598 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. LifeSource
Biologics Blood and Blood Products for Reprocessing W286814018598 Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. LifeSource
Biologics Source Plasma TT0457493; TT0458563 Class II Blood products, collected from a donor who had been incarcerated, were distributed. BPL Plasma, Inc.
Food La Terra Fina Organic Thick & Creamy Spinach Dip and Spread; Made with Greek Yogurt. 24 oz. plastic tub (1 lb. 8 oz,) 680 g: Keep refrigerated UPC 640410513730. Manufactured by" La Terra Fina, Union City, CA 94587 All units with Best-By Dates of: 3/24/2015 4/01/2015 4/14/2015 4/20/2015. 4/29/2015 - this expiry date was not distributed and is still at the facility. Class I Firm was notified by their supplier of IQF chopped spinach that the product that tested positive for Listeria Monocytogenes had been erroneously shipped. La Terra Fina, Inc.
Food La Terra Fina Spinach Artichoke & Parmesan Dip made with Greek Yogurt 31-ounce tub Keep refrigerated UPC 6-40410-51338-9 Manufactured by" La Terra Fina, Union City, CA 94587 All units with Best-By Dates of: 4/14/2015 4/20/2015 Class I Firm was notified by their supplier of IQF chopped spinach that the product that tested positive for Listeria Monocytogenes had been erroneously shipped. La Terra Fina, Inc.
Food La Terra Fina Chunky Spinach Artichoke & Parmesan Dip 31-ounce tub Keep refrigerated 31-ounce tub; UPC: 6-40410-51193-4 Item number 407600 - Costco Item number 4300193 - Smart and Final 10 oz. Retail size - UPC 6-40410-51327-3 Manufactured by La Terra Fina, Union City, CA 94587 All units with Best-By Dates of: Costco: 3/31/2015 4/4/2015 5/9/2015; Smart and Final: 3/28/2015 5/9/2015 10 oz. retail size - Best by 4/4/15. Class I Firm was notified by their supplier of IQF chopped spinach that the product that tested positive for Listeria Monocytogenes had been erroneously shipped. La Terra Fina, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036812520180; Class II Blood product in which routine testing/testing performed, interpreted, or documented incorrectly, was distributed. OneBlood, Inc.
Drugs 0.9% Sodium Chloride Injection, USP, 250 mL, Rx only, VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-25. Lot # 45-110-C6; Exp 03/1/16 Class I Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution. Hospira Inc.
Food Giant Eagle Store cut Fontal Cheese wrapped in plastic wrap Belgium Imported Fontal - CD; Sell By: (up to and including) 04/23/2015 PLU: 16124 Giant Eagle Distributed by: Giant Eagle, Inc., Pittsburgh, PA 15238 Sell By: (up to and including) 04/23/2015 Class I Retail store cut cheese packages did not declare the presence of Lysozyme, an egg allergen. Giant Eagle, Inc.
Devices 3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards. Part Number: 0215-015-000 and lot numbers: 10090012 10272012 11110012 11264012 12044012 12249012 13144012 14035012 10104012 10292012 11126012 11269012 12051012 12264012 13176012 14057012 10123012 10320012 11143012 11287012 12081012 12297012 13217012 14088012 10141012 10334012 11146012 11298012 12116012 12339012 13247012 14167012 10158012 10344012 11146022 11318012 12139012 12353012 13266012 14168012 10187012 11005012 11159012 11337012 12152012 13003012 13276012 14213012 10208012 11041012 11194012 11346012 12159012 13008012 13294012 14253012 10228012 11048012 11213012 12011012 12179012 13105012 13312012 14265012 10236012 11075012 11244012 12023012 12228012 13119012 13338012 Class II Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging Stryker Instruments Div. of Stryker Corporation
Devices 3/16 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards. Part Number: 0215-015-200 and lot numbers: 10074012 10280012 11110012 11271012 12066012 12349012 13225012 14022012 10105012 10294012 11138012 11298012 12080012 13016012 13260012 14070012 10118012 10315012 11151012 11346012 12091012 13077012 13268012 14163012 10155012 10319012 11185012 11356012 12181012 13115012 13303012 14169012 10215012 10344012 11189012 12025012 12275012 13120012 13323012 14195012 10242012 11025012 11264012 12053012 12290012 13148012 13346012 14246012 10252012 11033012 Class II Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging Stryker Instruments Div. of Stryker Corporation
Devices 1/8 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards. Part Number: 0215-018-000 and lot numbers: 10076012 10284012 11108012 11280012 12110012 12334012 13158012 14020012 10095012 10292012 11117012 11298012 12131012 12338012 13182012 14050012 10103012 10295012 11125012 11305012 12143012 12339012 13191012 14056012 10112012 10307012 11136012 11308012 12153012 12348012 13220012 14059012 10125012 10319012 11143012 11339012 12158012 12352012 13227012 14076012 10133012 10335012 11145012 11343012 12160012 13011012 13238012 14083012 10137012 10342012 11146012 11356012 12164012 13035012 13239012 14147012 10160012 10356012 11157012 12012012 12181012 13050012 13261012 14165012 10175012 11010012 11161012 12019012 12188012 13059012 13262012 14169012 10188012 11014012 11187012 12030012 12242012 13078012 13274012 14174012 10205012 11026012 11204012 12051012 12255012 13091012 13281012 14189012 10222012 11032012 11221012 12053012 12262012 13099012 13298012 14190012 10228012 11043012 11230012 12055012 12277012 13106012 13323012 14231012 10237012 11053012 11249012 12061012 12292012 13113012 13324012 14233012 10252012 11069012 11251012 12065012 12303012 13138012 13340022 14245012 10266012 11088012 11265012 12081012 12313012 13144012 13351012 14280012 10273012 11103012 11269012 12091012 12317012 13155012 14017012 14344012 Class II Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging Stryker Instruments Div. of Stryker Corporation
Devices 1/8 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards. Part Number: 0215-018-200 and lot numbers: 10082012 10266012 11089012 11222012 12047012 12240012 13121012 14034012 10099012 10289012 11109012 11231012 12059012 12256012 13145012 14072012 10105012 10309012 11122012 11241012 12072012 12283012 13156012 14083012 10118012 10319012 11129012 11252012 12080012 12319012 13194012 14164012 10134012 10323012 11136012 11271012 12125012 12332012 13235012 14170012 10168012 10342012 11143012 11305012 12144012 12349012 13260012 14234012 10180012 11012012 11151012 11337012 12152012 13015012 13275012 10217012 11035012 11168012 11355012 12157012 13039012 13317012 10229012 11052012 11188012 12004012 12178012 13057012 13343012 10256012 11070012 11199012 12027012 12198012 13086012 14016012 Class II Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging Stryker Instruments Div. of Stryker Corporation
Devices 1/4 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards. Part Number: 0215-019-000 and lot numbers: 10095012 10312012 11060012 11186012 11346012 12115012 12349012 13262012 10109012 10321012 11067012 11192012 11356012 12157012 13017012 13277012 10127012 10347012 11088012 11220012 12003012 12193012 13023012 13347012 10189012 10355012 11097012 11230012 12009012 12206012 13044012 14020012 10195012 11011012 11117012 11269012 12026012 12235012 13063012 14030012 10274012 11039012 11136012 11286012 12031012 12290012 13145012 14039012 10285012 11059012 11178012 11335012 12060012 12310012 13254012 14066012 Class II Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging Stryker Instruments Div. of Stryker Corporation
Devices 1/4 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards. Part Number: 0215-019-200 and lot numbers: 14122012 Class II Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging Stryker Instruments Div. of Stryker Corporation
Devices 3/16 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards. Part Number: 0215-031-000 and lot numbers: 10074012 10231012 10337012 11122012 11348012 12172012 13081012 14044012 10104012 10263012 11012012 11185012 12053012 12237012 13126012 14147012 10147012 10279012 11055012 11216012 12082012 12318012 13163012 14153012 10153012 10309012 11110012 11252012 12116012 12331012 13211012 Class II Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging Stryker Instruments Div. of Stryker Corporation
Devices 1/4 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards. Part Number: 0215-032-000 and lot numbers: 10098012 10279012 11017012 11131012 12033012 12275012 13128012 14063012 10165012 10343012 11122012 11159012 12137012 13025012 13343012 14105012 Class II Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging Stryker Instruments Div. of Stryker Corporation
Devices 3/16 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards. Part Number: 0225-015-000 and lot numbers: 10083012 10349012 11224012 12151012 13092012 13196012 14034012 14246012 10125012 11014012 11257012 12286012 13119012 13248012 14127012 14263012 10162012 11059012 12039012 12341012 13135012 13274012 14165012 10273012 11108012 12075012 13010012 13172012 13326012 14177012 10309012 11160012 12080012 13065012 13191012 14021012 14231012 Class II Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging Stryker Instruments Div. of Stryker Corporation
Devices 1/8 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards. Part Number:0225-018-000 and lot numbers: 10081012 10272012 11060012 11223012 12074012 13002012 13254012 14167012 10123012 10295012 11104012 11259012 12115012 13022012 13290012 14174012 10138012 10321012 11124012 11284012 12201012 13053012 13318012 14252012 10162012 10334012 11137012 11320012 12250012 13060012 13345012 10182012 10341012 11143012 11361012 12293012 13095012 14031012 10228012 11007012 11188012 12018012 12317012 13138012 14085012 10245012 11043012 11207012 12046012 12340012 13221012 14149012 Class II Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging Stryker Instruments Div. of Stryker Corporation
Devices 1/4 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards. Part Number:0225-019-000 and lot numbers: 10111012 11018012 11273012 12296012 13066012 13175012 14029012 14143012 10131012 11115012 12237012 Class II Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging Stryker Instruments Div. of Stryker Corporation
Devices Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main components: the suction reservoir, the PVC tubing, the slide clamp and the female connector. The rigid polycarbonate female connector is used to connect the ambulating bulb to the CBCII evacuator tube in order to collect wound drainage. Part Number:0225-028-852 and lot numbers: 10097012 10281012 11087012 11178012 12066012 12335012 13234012 14178012 10105012 10298012 11095012 11189012 12101012 12348012 13248012 14197012 10130012 10312012 11105012 11206012 12108012 12353012 13263012 14254012 10162012 10322012 11115012 11229012 12138012 13046012 13302012 14260012 10172012 10337012 11130012 11269012 12156012 13086012 13319012 10195012 10340012 11139012 11313012 12159012 13095012 14029012 10205012 11003012 11146012 11337012 12199012 13108012 14052012 10238012 11013012 11147012 12016012 12248012 13143012 14058012 10251012 11048012 11151012 12040012 12261012 13171012 14155012 10272012 11055012 11160012 12041012 12289012 13221012 14164012 Class II Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging Stryker Instruments Div. of Stryker Corporation
Food Pregestimil ready to use 20 calorie, 2 oz bottle; 6 bottles per carton; 8 cartons per case EV5A6F Class II Some Pregestimil 20 Calorie Nursette Bottles from batch EV5A6F were inadvertently packaged in Pregestimil 24 Calorie Nursette cartons. The individual Nursette bottles are correctly labeled as 20 Calorie. The carton is the cardboard sleeve wrapped around 6 bottles, the bottle labels and the outer corrugated case all correctly state 20 calorie. Mead Johnson Nutrition
Devices Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis of breast cancer. Serial Number: 26320119 Class II User Manual lacks a description for handling some errors even though the system can be recovered from such errors Fujifilm Medical Systems U.S.A., Inc.
Cosmetics Clean & Clear® Morning Burst Hydrating Gel Moisturizer Net Wt. 3 oz. (85 g( Distributed by Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. Skillman, NJ 08558-9418 Tube: 381371156870 Case Code(s): 111568700 Case GTIN: 10381371156877 (also known as Outer Case Code) 0125E01 Class III Clean & Clear® Morning Burst Hydrating Gel Moisturizer and Neutrogena® Hydro Boost Water Gel was manufactured with a combination of the raw materials 1,3 Butylene Glycol and Dimethicone, rather than only Dimethicone as intended and as listed on the product labeling. Johnson & Johnson
Cosmetics Neutrogena Hydro Boost Water Gel Net Wt. 1.7 oz (48 g) Dist. by Neutrogena Corp., L.A., CA 90045 Carton: 070501110478 Case Code(s): 681104700, 11047 V-00 Case GTIN: 10070501110475 (also known as Outer Case Code) Lot # 0145E02 Lot # 0155E02 Lot # 0165E02 Class III Clean & Clear® Morning Burst Hydrating Gel Moisturizer and Neutrogena® Hydro Boost Water Gel was manufactured with a combination of the raw materials 1,3 Butylene Glycol and Dimethicone, rather than only Dimethicone as intended and as listed on the product labeling. Johnson & Johnson
Food Deer Raisin Golden 7 oz., marked and unmarked packages Packed for Best Foods Inc. Edison, NJ 08817 Some have UPC 714760029255. packaged in clear plastic packages. unmarked and marked packages no lot code listed Class I Deer Brand Golden Raisin contain undeclared sulfites discovered through NYSDAM laboratory sampling. Best Foods NJ, Inc.
Devices CONTIPLEX® Continuous Peripheral Nerve Block Tray, CONTIPLEX® Stirn Continuous Nerve Block Tray, Custom Epidural and Anesthesia Tray, Custom Epidural Anesthesia Tray, Custom Kit, Custom Single Dose Epidural Anesthesia Tray, Custom Spinal Anesthesia Tray, Custom Spinal Epidural Anesthesia Tray, ESPOCAN® Combined Spinal and Epidural Anesthesia Tray, PERIFIX® Continuous Epidural Anesthesia Tray, PERIFIX® FX Continuous Epidural Tray, PERIFIX® One Continuous Epidural Pediatric Tray; Utilization of Product: Injection of local anesthetics to provide regional anesthesia for pain management. Route of administration is injection into subarachnoid space or epidural space or tissue surrounding peripheral nerve bundle(s). Custom Epidural and Anesthesia Tray Product codes: 331706 332128 331756 551474 551572 551727 551749 551769 551771 551773 551858 551889 551922 551942 552011 555098 555170 555215 555217 555325 555422 530132 530155 551273 551845 551970 551992 555212 555876 560123 560473 530035 530068 333194 333192 332211 332282 332079 332097 332086 332292 Batch Numbers: 61415053 61416382 61416362 61415022 61414464 61415024 61416390 61415028 61415921 61415924 61415023 61414468 61415044 61415051 61415037 61411483 61418020 61418077 61416399 61415041 61416385 61414419 61414589 61415712 61412398 61413393 61414485 61414481 61414591 61417210 61412387 61415001 61415013 61418035 61414411 61413390 61416395 61414492 61415040 61414417 61411528 61415708 expiration dates: 7/31116 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 6/30/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 1/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 9/30/16 7/31/16 6/30/16 6/30/16 3/31/17 2/28/17 7/31/16 7/31/16 7/31/16 1/31/18 7/31/16 7/31/16 6/30/16 7/31/16 2/28/17 6/30/16 1/31/17 Class II There is a potential for a hole to be present in the outer tray of a limited number of pain control trays. This issue has a low rate of occurrence, but may cause the integrity of the sterile barrier to be compromised. A compromised sterile barrier poses a risk of inflammatory response and/or possible contamination of the spinal fluid or epidural space. At this time, there have been no field reports or patient harm/adverse impact noted as a result of this issue. B. Braun Medical, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W115115067965I; W115115067965I; Class II Blood products, in which Quality Control and Distribution of product did not meet specifications, were distributed. Lifesouth Community Blood Centers - Montgomery Region
Biologics Red Blood Cells Leukocytes Reduced W127814503892; Class II Blood products, in which Donor Screening/Deferral screening was not done or incorrectly performed, including incorrect ID used during search,prior deferral due to history, were distributed. Tacoma-Pierce County Blood Bank
Biologics Fresh Frozen Plasma W127814503892; Class II Blood products, in which Donor Screening/Deferral screening was not done or incorrectly performed, including incorrect ID used during search,prior deferral due to history, were distributed. Tacoma-Pierce County Blood Bank
Biologics Red Blood Cells Leukocytes Reduced W035214331694I; Class II Blood products, in which donor screening/donor record incomplete or incorrect, were distributed. Carter BloodCare
Biologics Blood and Blood Products for Reprocessing W035214331694I; Class III Blood products, in which donor screening/donor record incomplete or incorrect, were distributed. Carter BloodCare
Food Wawa brand Kale and Quinoa Salad, 7.5-oz. plastic container, UPC Code: 726191066402 Lot Code: TFFLD076A1 Class I Undeclared soy allergen on labeling Taylor Farms Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced W088413504905; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Blood Bank Of Hawaii
Biologics Red Blood Cells Leukocytes Reduced W088415501020; W088414541049; Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Blood Bank Of Hawaii
Biologics Platelets W333615027326; Class II Blood product, in which Quality Control and Distribution of product did not meet specifications, was distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells Leukocytes Reduced W202215238539; W202215239074; W202215239065; Class II Blood product in which routine testing/testing performed, interpreted, or documented incorrectly, was distributed. Northeastern Pennsylvania Region of American Red Cross
Drugs Alinia (nitazoxanide), powder for oral suspension, 100mg/5mL, 60 mL/bottle. Rx only, Manufactured for Lupin Pharmaceuticals Inc, Baltimore, Maryland 21202 for Romark Laboratories 3000 Bayport Dr. Suite 200, Tampa, FL 33607 Lot #: MTEW1721, MTCW21281, MTCW21291, Exp 09/2016; Lot #: MTEW5791, Exp 12/2016; Lot #: MTEW5801, Exp 01/2017. Class II Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity Romark Laboratories, L.C.
Drugs C-Topical 4% CII (cocaine hydrochloride), topical solution, 4 ml bottle, (NDC 0527-1728-74), Rx Only, Manufactured for Lannett Company, Inc. Philadelphia, PA 19136 by Cody Laboratories, Inc. Cody, WY 82414 Lot 14834012, Exp 01/2016 Class II Labeling: Label mix-up; bottles were incorrectly labeled as 10 mL instead of correctly labeled as 4 mL Cody Laboratories, Inc.
Food Whole Foods Market Health Starts Here Rye Bread (formerly 100% Rye) 16 oz. PLU# 41844 No code information Class II Undeclared Wheat Whole Food Market
Devices Universal Charger Product Usage: The Stryker Universal Battery Charger is designed to be used in conjunction with and provide power to non-sterile and sterile batteries. The Stryker Universal Battery Charger is a four station, modular battery charger intended to charge Stryker handpiece battery packs only. The battery charger has the optional functionality to track device usage data. Usage data is accumulated by Stryker and reports are able to be provided to the customer. Part No. 7110-120-000; Affected serial numbers as follows: 1234701323, 1402902743, 1402902893, 1221503173, 326305393, 1217705113, 1315004963, 1222700863, 1326305403, 1217705123, 1315005013, 1222701093, 1217705283, 1324801023, 1217705083, 1322600723, 1217900123, 1324801083, 1217705093, 1305900203, 1210305253, 1407105433, 1217705133, 1306611063, 1400202023, 1409403273, 1334302313, 1307105733, 1400202103, 1205304123, 1334302333, 1307801973, 1402104293, 1205304133, 1334302363, 1307801983, 1402205583, 1207500553, 1334302413, 1307801993, 1301614823, 1426000013, 1334302433, 1207500593, 1301700663, 1326902543, 1305903843, 1207500603, 1326902613, 1326902563, 1333709623, 1302910113, 1327000033,  ...
More
Class III The Stryker Universal Battery Charger is not transmitting usage data to the Stryker Cloud as designed. The firm is initiating a software correction to address the issue. Stryker Instruments Div. of Stryker Corporation
Food Krystyna Bakery Polish Style Cheese Cake, Weight 18 oz., UPC 789438000096 None Class II Polish Style Cheese Cake contains undeclared ingredients, whole blueberries, FD&C Blue #1, Red #3, Red #40, Yellow #5 and Yellow #6. Krystyna Bakery
Biologics Platelets Pheresis Leukocytes Reduced Washed W201215873123; Class II Blood product, labeled with an incorrect expiration date, was distributed. The American National Red Cross - Southern Region
Devices ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures. Software Versions: ExacTrac v. 6.x (v. 6.0.0, 6.0.1, 6.0.2, 6.0.3, 6.0.4, 6.0.5; and v. 6.1.0); Model/Catalog Numbers: 49971, CBCT IMPORT & ALIGNMENT SOFTWARE; 20836, EXACTRAC 6.0 VARIAN CBCT LICENSE; 48320, ET UPGRADE SOFTWARE 6.0 TO 6.1; 48320-99, ET UPGRADE SOFTWARE 6.0 TO 6.1 SLA; 49973B, ET DATA PREP / REVIEW  ...
More
Class II ExacTrac 6.x Patient Positioning System: Potentially incorrect patient positioning when using the ExacTrac Cone Beam CT (CBCT) with a CBCT acquired at a couch angle other than 0.0 degrees. Brainlab AG
Devices BARD MAX-CORE Disposable Core Biopsy Instrument Gauge x Length 18g x 20cm The BARD MAX-CORE Disposable Core Biopsy Instrument is a single patient use core biopsy device. It is available in several needle gauge sizes and lengths. The side and rear actuator buttons are color-coded according to the various gauge sizes e.g., yellow=20 gauge, pink=18 gauge, purple=16 gauge, and green=14 gauge. Product Code: MC1820 Gauge x Lengh: 18g x 20cm Lot Numbers: REYA2017, REYC2853 Class II The firm is recalling Bard MAX-CORE Disposable Core Biopsy Instrument due to the risk of having self-activation-related issues. Bard Peripheral Vascular Inc
Biologics Red Blood Cells Leukocytes Reduced W038114039470; Class II Blood products, in which donor screening/deferral screening were not done or incorrectly performed, were distributed. OneBlood, Inc.
Biologics Plasma Cryoprecipitated Reduced W038114039470; Class II Blood products, in which donor screening/deferral screening were not done or incorrectly performed, were distributed. OneBlood, Inc.
Biologics Cryoprecipitated AHF, Pooled W038114980465; Class II Blood products, in which donor screening/deferral screening were not done or incorrectly performed, were distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced W051514142594; W051514105408; W051514025963; Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Innovative Blood Resources
Food Earth Coco Raw Coconut Water 100% Pure -320ml UPC 799632-585022 -500ml UPC 799632-585015 Distributed by: Earthcoco, Inc. 2651 Main Street Santa Monica CA 90405 www.earthcoco.com Product of Philippines **store frozen for maximum freshness** 320ml and 500ml lot code: 317011-317251, 319011-319321, 329012-329371, 340012-340071, 218011-218421, 218431-218521 Class II The firm is recalling EarthCoco Pure Coconut Water 320ml and 500ml because they lack a 5-log reduction process. Earthcoco
Devices NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Intended to be used in total knee arthroplasty when there is insufficient bone in the distal femur. Part #00-5990-036-10; lot 62815809 Class II The affected lot is being recalled because it was packaged without the locking screw. The locking screw packaged with the augment is used to fix the augment to the femoral component. This has the potential to delay surgery Zimmer, Inc.
Food TRADER JOES A Dozen Sweet Bites Chocolate and Coffee Opera Cake, Raspberry Macaroon Cake, Caramel & Chocolate Cake, 9.16 oz UPC 00967679 or SKU 096767. Batch No. 01613PR 01713PR 01813PR 04413PR 04513PR 04613PR 04913PR 04613PR 04931PR 07313PR 07413PR 07713PR 07813PR 11613PR 11913PR 12713PR 11913PR 12013PR 12213PR 11613PR 13413PR 18613PR 18213PR 18313PR 18413PR 22613PR 22413PR 22513PR 22613PR 22813PR 13612 PR 32012PR 01513PR 01613PR 01613PR 01713PR 03713PR 04413PR 04513PR 07413PR 07713PR 07813PR 12213PR 17913PR 18213PR 18313PR 18413PR 17913PR 18313PR 18413PR 22513PR 23413PR 26113PR 22513PR 22613PR 23113PR 23213PR 23313PR 25913PR 25913PR 26013PR 26213PR 01014PR 01214PR 01414PR 03414PR 03514PR 03014PR 03114PR 05114PR 05714PR 09414PR 05214PR 05114PR 05714PR 09714PR 09714PR 09814PR 09914PR 13614PR 13914PR 14014PR 14114PR 14214PR 14314PR 13914PR 16814PR 16914PR 17014PR 02914PR 17014PR 17114PR 17614PR 19214PR 23014PR 24414PR 24414PR 24514PR 24614PR 26213PR 01014PR 01314PR 01014PR 03414PR 03514PR 03614PR 05014PR 05114PR 05614PR 05714PR 09814PR 14014PR 13614PR 09414PR 13914PR 16814PR 16914PR 17014PR 17114PR 17414PR 02914PR 09414PR 19014PR 19114PR 24514PR 24614PR 14214PR 14314PR 18814PR 18914PR 19114PR 01215PR 01315PR 01415PR 02015PR 03015PR 03315PR 03615PR 19114PR 24614PR 01315PR 01215PR 02015PR 03015PR 03315PR Class II Prolainat is recalling all lots of 9.16 oz packages of Trader Joes A Dozen Sweet Bites (Chocolate & Coffee Opéra Cake, Raspberry Macaron Aux Framboises Cake, Caramel & Chocolate Cake) due to undeclared coconut. PROLAINAT
Devices 119" (302 cm) Transfer Set w/MicroClave T-Connector, Smallbore Quadfuse Ext Set w/3 MicroClave (Red, Glow Rings), 5 Check Valves, 0.2 Micron Filter, Rotating Luer, Non-DEHP Tubing, Item No. B33037 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile. Lot No. 2977625 2992751 2995225 Class II ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage. ICU Medical, Inc.
Devices 107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non-DEHP Tubing, Item No. B33041 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile. Lot No. 3002665 3004236 2995225 Class II ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage. ICU Medical, Inc.
Devices 104" (264 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Smallbore Trifuse Ext w/2 MicroClave, Anti-Siphon Valve, 3 Clamps (White, Red, Blue), Rotating Luer, Non-DHEP Tubing, Item No. B33065 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile. Lot No. 2992752 2997916 3004237 3019517 3026353 Class II ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage. ICU Medical, Inc.
Devices 113" (287cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Smallbore Quadfuse Ext Set w/MicroClave, 4 Clamps (Blue, 2 Red, White), Rotating Luer, Non-DEHP Tubing, Item No. B33303 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile. Lot No. 2992754 3004256 3007508 Class II ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage. ICU Medical, Inc.
Devices 108" (274 cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33326 Lot No. 2997915 2997919 2997920 2998568 2998569 3001232 3001233 3001234 3004257 3015880 3015881 3019519 3020159 Class II ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage. ICU Medical, Inc.
Devices 127" (323cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33351 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile. Lot No. 2997914 2997918 2998570 3001230 3001231 Class II ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage. ICU Medical, Inc.
Devices 98" (249 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Trifuse Ext Set w/2 MicroClave, Rotating Luer, Non-DEHP Tubing, Item No. B3338 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile. Lot No. 2997914 2997918 2998570 3001230 3001231 Class II ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage. ICU Medical, Inc.
Devices 98" (249 cm) Transfer Set w/MicroClave T-Connector, 2 Check Valves, Luer Lock, Non-DEHP Tubing, Item No. B3372 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile. Lot No. 3019521 Class II ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage. ICU Medical, Inc.
Devices AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions. The intended use and indications for use of this modified device as described in its labeling have not changed from its predicate device. Model Number of device: 7414803, Serial #s: 1008 1121 1016 1156 1157 1056 1043 1126 1076 1137 1088 1093 1030 1033 1029 1032 1100 1124 1139 1050 1058 1078 1127 1040 1035 1155 1143 1074 1109 1135 1007 1131 1110 1081 1064 1145 1146 1147 1059 1122 1140 1003 1083 Class II If the cable cart and the corrugated hose are unable to move freely, the cable holder could drop down and hit patients or system operators. Siemens Medical Solutions USA, Inc
Food Blintzes with Cherry, Net Wt. 18oz (510g), 10 pieces. 18-oz. plastic trays containing ten pieces of Royal Frozen Food, BLINTZES Blintzes with Cherry with bar code 6 0723830021 8; 12 packs per case. UPC 6 0723830021 8 Class I Royal Frozen Food is recalling Royal Frozen Food Blintzes because they contain undeclared milk. Royal Frozen Food
Food Blintzes with Potato, Net Wt. 18oz (510g), 10 pieces. 18-oz. plastic trays containing ten pieces of Royal Frozen Food, BLINTZES Blintzes with Potato with bar code 6 0723830020 1; 12 packs per case. UPC 6 0723830020 1 Class I Royal Frozen Food is recalling Royal Frozen Food Blintzes because they contain undeclared milk. Royal Frozen Food
Food Blintzes with Potato & Mushroom, Net. Wt. 18oz (510g), 10 pieces. 18-oz. plastic trays containing ten pieces of Royal Frozen Food, BLINTZES Blintzes with Potato Mushroom with bar code 6 0723830020 1. 12 packs per case. UPC 6 0723830020 1 Class I Royal Frozen Food is recalling Royal Frozen Food Blintzes because they contain undeclared milk. Royal Frozen Food
Biologics Cornea 20150069OSCN Class II Human cornea, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed. Old Dominion Eye Foundation, Inc.
Biologics Cornea 20150050ODCN; 20150050OSCN; Class II Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. Old Dominion Eye Foundation, Inc.
Biologics Cornea 20140220OSCN Class II Human cornea, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed. Old Dominion Eye Foundation, Inc.
Devices ViewRay System, Radiation Therapy System M/N 10000, S/N 100 only Class II The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate correction for non HFS (Head First Supine) patient orientations, resulting in slice mismatch error. Viewray Incorporated
Food OSSIE'S HERRING IN SOURCREAM, NET WT. 8 OZ, UPC 739885114174 --- The product is packaged in clear, plastic containers/tubs. date code 06/08/15 (represents expiration date and located on the bottom of the tub) Class I The product contains undeclared milk, a sub-ingredient of the sour cream used in the product. SM Fish Corp
Food OSSIE'S PICKLED LOX DAIRY, NET WT. 8 OZ, UPC 739885114136 --- The product is packaged in clear, plastic containers/tubs. date code 06/08/15 (represents expiration date and located on the bottom of the tub) Class I The product contains undeclared milk, a sub-ingredient of the sour cream used in the product. SM Fish Corp
Food OSSIE'S PICKLED LOX & CREAM, NET WT. 8 OZ, UPC 739885114136 --- The product is packaged in clear, plastic containers/tubs. date code 06/04/15 (represents expiration date and located on the bottom of the tub) Class I The product contains undeclared eggs, a sub-ingredient of the mayonnaise used in the product. SM Fish Corp
Devices EPIQ 5 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W. Catalog Number: 795204 / 795205. Part Number: 989605408541 With 453561736761 (1.1) 453561750041 (1.1.1) 453561753651 (1.1.2) 453561772231 (1.2) 453561772611 (1.2.1) 453561786571 (1.2.2) 453561785081 (1.3) 453561800581 (1.3.1) 453561805181 (1.3.2) *********************SYSTEM CODES IN THE US*********************************** US114C0108, US114C0206, US114C0210, US114C0239, US114C0240, US114C0241, US114C0271, US114C0272, US114C0273, US114C0286, US114C0321, US114C0322, US114C0331, US114C0332, US114C0333, US114C0334, US114C0444, US114C0534, US114C0605, US114C0674, US115C0140, US115C0382, US115C0468, US214C0106, US214C0143, US214C0144, US214C0192, US214C0534, US214C0535, US214C0536, US215C0071, US215C0394, US215C0536, US215C0774, US215C0839, US215C0843, US215C0844, US215C1010, US215C1049, US215C1050, US314C0055, US314C0073, US314C0235, US314C0296, US314C0297,  ...
More
Class II When Epiq 5 Ultrasound System, WITH the Pediatric Cardiology option, is set up to Metric and weight and/or height is entered, a unit conversion error may result in the incorrect calculation of the patients Body Surface Area (BSA). Philips Ultrasound, Inc.
Devices EPIQ 7 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number: 795200 / 795201. Part Number: 989605386721 With: 453561726491 (1.0) 453561728121 (1.0.1) 453561736781 (1.1) 453561750021 (1.1.1) 453561753631 (1.1.2) 453561772251 (1.2) 453561772631 (1.2.1) 453561786591 (1.2.2) 453561785101 (1.3) 453561800601 (1.3.1) 453561805211 (1.3.2) ) ************************SYSTEM CODES IN THE US**************************** US114B0149, US114B0158, US114B0159, US114B0161, US114B0168, US114B0169, US114B0171, US114B0172, US114B0186, US114B0223, US114B0225, US114B0226, US114B0227, US114B0228, US114B0229, US114B0268, US114B0269, US114B0304, US114B0305, US114B0306, US114B0307, US114B0336, US114B0337, US114B0356, US114B0357, US114B0358, US114B0359, US114B0360, US114B0395, US114B0399, US114B0402, US114B0434, US114B0436, US114B0437, US114B0440, US114B0441, US114B0462, US114B0463, US114B0464, US114B0465, US114B0466, US114B0467, US114B0472, US114B0477,  ...
More
Class II When Epiq 7 Ultrasound System, WITH the Pediatric Cardiology option, is set up to Metric and weight and/or height is entered, a unit conversion error may result in the incorrect calculation of the patients Body Surface Area (BSA). Philips Ultrasound, Inc.
Biologics Cornea 03102015049OD; 03102015049OS Class III Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. Mid-America Transplant Services
Biologics Cornea 10032014041OD; 10032014041OS Class II Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. Mid-America Transplant Services
Biologics Cornea 11122014058OD; 11122014058OS Class II Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. Mid-America Transplant Services
Drugs KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by RemedyRepack, Indiana, PA, mfg by Hospira, Inc. Lake Forest, IL NDC 61786-0055-01 Lot # B0069266-013015, Lot # B0069264-013015, Lot # B0066712-011415, EXP DATE 9/01/2016 Class II Crystallization RemedyRepack Inc.
Devices ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Typical examination performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis; Vascular Imaging Applications and Analysis; Superficial Imaging Applications; Intraoperative Imaging Applications; Transcranial Imaging Applications; Model 10433816, software versions VA16C, VA16D and VA16E. Device serial numbers: 400230 400708 400462 400467 400460 400461 400084 451021 400743 400225 450122 400634 400687 400023 400126 400265 400717 400740 400458 400459 400678 400665 450123 400617 400485 400083 400092 451024 400223 400404 450143 400650 400663 400664 400577 400470 400479 400493 400519 400318 400674 400463 400484 400679 400680 400589 400466 400168 400139 400270 400308 400236 400689 400691 450151 400693 400615. Class II In some cases, the system is unable to capture a clip or image during a routine scan. Siemens Medical Solutions USA, Inc.
Devices Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. PCPA PN: 010-1636-02 **************SERIAL NUMBERS OF MODULES IN THE US****************** 1496-000595, 1496-005414, 1496-005702, 1496-005703, 1496-005704, 1496-005708, 1496-005710, 1496-005713, 1496-005714, 1496-005743, 1496-005748, 1496-005759, 1496-005786, 1496-006113, 1496-008032, 1496-008591, 1496-008595, 1496-008598, 1496-008599, 1496-008601, 1496-008602, 1496-008603, 1496-008605, 1496-008607, 1496-008615, 1496-008616, 1496-008617, 1496-008619, 1496-008621, 1496-008622, 1496-008623, 1496-009099, 1496-009101, 1496-009103, 1496-011913, 1496-012487, 1496-015399, 1496-016027, 1496-021455, 1496-023173,  ...
More
Class II Modules resetting. This failure mode happens when the Spacelabs Command Module is configured with the Masimo SpO2 option (-M), the Spacelabs Respiration option (-R) and the Masimo SpO2 PCBA, PN: 010-1136-02. With these two options and the Masimo SpO2 PCBA present, the module may experience random resets. Spacelabs Healthcare Inc
Devices ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. Serial Numbers: 400935 400140 400532 400580 400582 400592 400597 400635 400643 400652 400685 400686 400733 400737 400746 400752 400753 400771 400777 400784 400833 400919 400499 400896 400809 400296 400111 400319 400793 400699 400849 400816 400213 400212 400215 400251 400254 400407 400560 400670 400713 400722 400729 400730 400731 400734 400764 400766  ...
More
Class II In certain situations, loss of post exercise images can occur in Stress Echo. Siemens Medical Solutions USA, Inc.
Show all Code Info
-
-