Worldwide distribution: USA (Nationwide) and country of: Canada.
Handset component of the Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss), Part Number BP300-100/BP300-400RSUS (handset) - Model Numbers BBR0311USAB (blue) and BBR0311USSS (silver)   Handset component devices operate the Minivator Bath Bliss Reclining Bath Lift, a non-AC-powered patient lift consisting of a motorized actuator, powered mechanical seating device, temporarily secured in a bath, and used to lift and lower a patient in the vertical or reclining position while bathing.
Handsets shipped with Bath Lifts belonging to the following serial numbers:  BH05100001 - BH05129999 and  BH06120001 - BH11129999; Handsets shipped as spare parts with the following serial numbers: BS05100001 - BS05129999 and BS06120001 - BS11129999.
Firm became aware that two handsets in the affected batches became inoperable while the user was in the tub.
Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E.    Fluroscopic X-Ray Systems
Siemens has discovered through product monitoring a potential malfunction when using system operating with software versions VB10D, VB10F, VB10C and VB10.  During a RAD examination the possibility exists that radiation may continue longer than expected and may result in unnecessary dose applied during an acquisition.  Additionally, it is not possible for the user to stop the radiation manually; however, there are emergency circuits active which will stop radiation through another independent mechanism.  If the image quality of the overexposed image is unacceptable for diagnosis, the examination could potentially have to be repeated.  The upgrade to software version VB10G resolves this potential malfunction.  For patients who were treated with affected systems in the past, no measures such as additional treatment or aftercare are necessary.
Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, IO, KS, LA, MA, MD, MI, MN, MO, NC, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV; and countries of: Australia, Brazil, Canada, Dubai, Germany, Japan, Kuwait, Malaysia, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, and Thailand.
DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only).   The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas
Serial Numbers: All serial numbers manufactured since inception in June 21, 2012 until June 12, 2013
Carestream Health Inc. is conducting a recall for the Column end Cover present on the DRX Revolution Mobile X-Ray System due to the cover dislodging from the column.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood products, collected from a donor who reported high risk behavior, were distributed.
Blood and Blood Products for Reprocessing
Nationwide distribution: USA including the states of AZ, CA, FL, GA, MO, NJ, NM, NC, OR, TN and WV.
Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories   The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors.
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.
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.
Human Cornea, recovered from a donor who was not properly assess for hemodilution, was distributed.
Human Corneas, recovered from a donor who was improperly assessed for hemodilution, were distributed.
Human tissue allografts, 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.
Amneal Pharmaceuticals of New York, LLC.
Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 --- Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141
Failed dissolution specifications; 18 month CRT
Distribution was made to CA, FL, HI, IA, IN, KS, MD, MI, MN, MO, MS, NE, NJ, NM, OK, OR, PA, TN, TX, WI, Firm also distributed to PR.
Virbac Iverhart Plus (ivermectin/pyrantel) Flavored Chewables, 136 mcg Ivermectin and 114 mg pyrantel as pamoate salt, 6 chewables/blister pack, Recommended for dogs 26 to 50 lbs. ANADA 200-302. Manufactured by Virbac A, Inc, Fort Worth, TX.   VETIQ HeartShield Plus  (ivermectin/pyrantel) Flavored Chewables, 136 mcg Ivermectin and 114 mg pyrantel as pamoate salt, 6 chewables/blister pack, Recommended for dogs 26 to 50 lbs. ANADA 200-302. NDC 49994-205-06. Manufactured for: TruRX, LLC, Eagle, ID.    Worm Shield (ivermectin/pyrantel) Flavored Chewables, 136 mcg Ivermectin and 114 mg pyrantel as pamoate salt, 6 chewables/box, Recommended for dogs 26-50 lbs. ANADA 200-302. Manufactured for: Schuyler LLC, Portland, OR.
Virbac Iverhart Plus Lot numbers and expiration dates of recalled product failing ivermectin potency: 120378, 03/2014; 120090, 01/2014; 120301, 02/2014; 120305, 02/2014; 120692, 05/2014  ****Lot numbers and expiration dates of recalled product with passing potentcy but expected to fail:  121282, 10/2014 and 120450, 02/2014.    Worm Sheild Lot numbers and expiration dates of recalled product failing ivermectin potency:  120090, 01/2014; 120301, 02/2014; 120305,02/2014.  ****Lot numbers and expiration dates of recalled product with passing potentcy but expected to fail:  120450, 04/2014    Heartshield Lot numbers and expiration dates of recalled product failing ivermectin potency: 120692, 05/2014.  ****Lot numbers and expiration dates of recalled product with passing potentcy but expected to fail:  NONE
The products were identified during an ongoing investigation and testing as being out-of-specification for Ivermectin potency.
Virbac Iverhart Plus (ivermectin/pyrantel) Flavored Chewables, 272 mcg Ivermectin and 227 mg pyrantel as pamoate salt, 6 chewables/blister pack, Recommended for dogs 51 to 100 lbs. ANADA 200-302. Manufactured by Virbac A, Inc, Fort Worth, TX.   VETIQ HeartShield Plus  (ivermectin/pyrantel) Flavored Chewables, 272 mcg Ivermectin and 227 mg pyrantel as pamoate salt, 6 chewables/blister pack, Recommended for dogs 51 to 100 lbs. ANADA 200-302. NDC 49994-305-06. Manufactured for: TruRX, LLC, Eagle, ID.    Worm Shield (ivermectin/pyrantel) Flavored Chewables, 272 mcg Ivermectin and 227 mg pyrantel as pamoate salt, 6 chewables/blister pack, Recommended for dogs 51-100 lbs. ANADA 200-302. Manufactured for: Schuyler LLC, Portland, OR.
Virbac Iverhart Plus (ivermectin/pyrantel) Flavored Chewables, 68 mcg Ivermectin and 57 mg pyrantel as pamoate salt, 6 chewables/box, Recommended for dogs up to 25 lbs. ANADA 200-302. Manufactured by Virbac A, Inc, Fort Worth, TX.   VETIQ Heart Shield plus (ivermectin/pyrantel), 68 mcg Ivermectin and 57 mg pyrantel as pamoate salt, 6 chewables/box, Recommended for dogs up to 25 lbs. Packaged 6 flavored chewables per blister pack. ANADA 200-302, NDC 49994-105-06. Manufactured for: TruRx, LLC, Eagle, ID.     Worm Shield (ivermectin/pyrantel) Flavored Chewables, 68 mcg Ivermectin and 57 mg pyrantel as pamoate salt, 6 chewables/blister pack, Recommended for dogs up to 25 lbs. ANADA 200-302. Manufactured for: Schuyler LLC, Portland, OR.
Lot numbers and expiration dates of recalled product failing ivermectin potency:   Iverhart Plus- 120092, 10/2013; 120397, 12/2013 and 120398, 11/2013.    Wormshield- 120397, 12.2013.    Heartshield- NONE    Lot numbers and expiration dates of recalled product with passing potentcy but expected to fail:     Iverhart Plus- 120195, 02/2014 and 120798, 02/2014.    Wormshield- 120195, 02/2014.    Heartshield- 120798, 02/2014.
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Southern California Permanente Medical Group Blood Donor Ctr
Blood product, labeled as leukoreduced without the assurance that it met the criteria for a leukoreduced product, was distributed.
Worldwide Distribution - USA (nationwide) including AZ, CA, FL, IN, MA, MD, TX, and WA and Internationally to Czech Republic, Germany, Netherlands, Spain, Switzerland, and Turkey.
MLS Torpedo Mini-Light Ophthalmic single-port illumination.   Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired.
The product was registered and distributed as a Class I medical device and was subsequently determined to be a Class II medical device which requires FDA market clearance.
Nationwide distribution:AL, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MI, MO, NE, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WI, and WV.
DRX- Revolution, Catalog number: 101937, 1023415 & 1023423.  Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608   to perform radiographic x-ray examinations on all pediatric and adult patients
Model: DRXR-1 Serial numbers: all serial numbers manufactured with version 5.5 software and version 69 firmware
Carestream Health Inc. has conducted a voluntary field action which includes the installation of a software patch on the following: DRX-Revolution Mobile X-Ray, DRX-Mobile and DRX Transportable Systems with DirectView Version 5.5 and 5.6 console software when used with DRX-1 Detector version 69 firmware. Carestream recently received reports of a non-diagnostic image on exams when a Normal Exposure Mode (NEM) image is taken immediately prior to an Extended Exposure Mode (EEM) image with the system in Fast Preview Mode. Investigation revealed that the DirectView version 5.5 and 5.6 console software when used with DRX-1 Detector version 69 firmware contained a timing issue which could result in a non-diagnostic image.
CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397.  Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608   to perform radiographic x-ray examinations on all pediatric and adult patients
Model: DRX Mobile Serial numbers: all serial numbers manufactured with version 5.5 software and version 69 firmware
Worldwide Distribution - USA (nationwide) and Internationally to China, Argentina, Uruguay, Japan.
Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured and distributed by  Bayer HealthCare LLC, Sunnyvale, CA       The A1CNow+ test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1c or %A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is for professional use to monitor glycemic control in people with diabetes.
Test results from these lots may produce a high-bias reading (by up to 20%) that is outside of limits defined for stability and product accuracy when product is stored at room temperature four (4) to five (5) months after release.
Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only,    Product Usage:  Edwards Lifesciences femoral access cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Femoral access cannulae may be used in pediatric populations or adult populations based on flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.
Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in the t-connector of the devices which were confirmed during product evaluation.
Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating, Sterile, RX only For Single Use Only,    Product Usage:  Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term (< 6 hours) cardiopulmonary bypass procedures. Aortic cannulae in sizes 6Fr to 18Fr can be used in pediatric patient populations. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.
Nationwide Distribution including MD, PA, and CT.
ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number:  SMN 10492387   For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems.
595 kits total (5 kits with packaging error)
PTH Calibrator packaged with only high calibrator.
Nationwide distribution: USA including the states of Alabama, Arkansas, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Virginia, Washington and Wisconsin.
Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH   Harmony Equipment Management Systems (EMS) are used in hospital facilities to provide ready access to medical gasses, electrical power and audio/visual data services, in addition to managing surgical support equipment such as endoscopic equipment, cautery devices and insufflators.
Drger Medical GmbH has notified STERIS of the potential for a break in the drive screw contained in the motorized ceiling supply unit, a component of the Harmony EMS system.  The ceiling supply unit controls the motorized adjustment of the height and rotation of the supply column.  Should a break occur in the drive screw, there is potential for the adjustable arm to drop down, causing the EMS system to lower unexpectedly.
Product was distributed to the following states:  GA, AR, OK, TX, and VA.
Bio-Cox Granular 60 Alpharma Brand of salinomycin sodium Type A Medicated Article Net Wt 50 LB, Marketed by Alpharma Inc. Bridgewater, New Jersey 08807, NADA # 128-686
Worldwide Distribution-USA (nationwide) including  Puerto Rico and Guam and the states of AZ, CA, CO, FL, IL, MA, MD, MO, MT, NC, ND, NJ, NV, NY, TX, VA, and WA and the country of Canada.
Pinook Mini Massager  Distributed by www.pinookusa.com.    Used to strengthen the abdominal muscles.
Failure to submit a premarket submission and gain approval of a medical device.
Pinook Micro Massager  Distributed by www.pinookusa.com    Used to strengthen the abdominal muscles.
Ti-Magna Fx Washer Ti-Versa-FXII Femoral Fixation System S/C Plates      The compression tube/plates of this trauma system are used with Ti-Versa-Fx II Femoral Fixation System lag screws for the internal fixation of proximal femoral and supracondylar fractures. The Ti-Magna Fx System is an osteosynthesis item for orthopedic use in open internal fixation of fractures of the femoral neck, condyle, or tibia, etc. The washer prevents the screw head from being buried in the bone.
Zimmer recently conducted a review of historic packaging validations completed.  Based on this review, it was determined that a subset of product packaged at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity.  The number of samples required for packaging testing, to provide statistical confidence (90% confidence in 99% reliability), were not available for the Ti MagnaFx Washer and Ti VersaFx S/C 90 degree and 95 degree plates. A voluntary recall will be conducted of all potentially affected products. The voluntary recall is limited to Japan as these products are distributed only in Japan
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product contains 1,3 dimethylamylamine (DMAA)
COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas.  COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed tube sampling accessory     A fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids.
Roche COBAS INTEGRA 800 system, Software Version 9864.C2 does not perform necessary ISE Service Actions. Whenever the ISE rack is removed, the ISE counters in the software are reset to zero and the corresponding Service Actions are not conducted automatically by the system.  Additionally, certain maintenance activities that have to be performed manually by the operator are not requested on the software by the due date. This software issue ONLY affects systems performing ISE tests.
Worldwide Distribution - USA (nationwide) and the country of Canada.
Dual Luer Lock Cap   The device is intended for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets.
The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging. Particulate matter entering the fluid path from the Luer lock caps may result in embolic events.
Worldwide Distribution-USA (nationwide) and the countries of  Canada, Vietnam, Zambia, and Zimbabwe.
ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer.   Automated chemistry analyzers that measures analytes in samples.
The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference) valve failure.  Premature valve failure can be detected by the presence of air bubbles in the ISE REF solution tubing on the ISE unit.  If air bubbles are present, accuracy of the ISE test results may be affected.
ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer.   Automated chemistry analyzers that measures analytes in samples.
Worldwide Distribution - USA (nationwide) and Mexico.
Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay
Nationwide and Puerto Rico, Canada, Mexico, and clinical distribution in Europe.
Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton, Rx only, Manufactured by: Amgen Manufacturing Ltd., a subsidiary of Amgen Inc., Thousand Oaks, CA  91320-1799,NDC 55513-710-01, UPC 3 55513 71001 5.
Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.
Worldwide Distribution - US including the states of  KY and UT and the country of Sweden.
Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum.     The kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL.    The vial's label shows CALCIUM ARSENAZO, CALA-5220, 20 mL, .    CALCIUM ARSENAZO is intended use for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). It is not intended for use in Point of Care setting.
Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high results than serum.
Fresenius Liberty Cycler Part Number: RTLR180111    Product Usage:  The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis.
Fluid leaking may be observed inside the pump compartment of the Liberty Cycler  and  may result in dialysate becoming contaminated, potentially causing peritonitis
Nationwide Distribution including AK, AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, VT, WA, WI, WY.
Portex Spinal Tray with Drugs  22g Whitacre/25g Whitacre; 15248C-22/25   The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure.
Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK.  These ampules are included in certain Portex Spinal Anaesthesia Trays.
Portex Spinal Tray with Drugs  22g/25g Quincke; 15249-21   The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure.
Portex Spinal Tray with Drugs 25g Whitacre; 15545C-21   The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure.
Portex Regional Anesthesia Tray with Drugs; 15548-20   The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure.
Portex Spinal Tray with Drugs 25g Whitacre; 15597-20   The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure.
Portex Spinal Tray with Drugs 25g Whitacre; 15597C-20   The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure.
Portex Saddleblock Tray with Drugs  26g Quincke, 4745-20   The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure.
Portex Saddleblock Tray with Drugs  22g Quincke (Without Introducer); 4792-20   The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure.
Portex Saddleblock Tray with Drugs  25g Quincke; 4795-20   The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure.
Nationwide Distribution including Arizona andTexas.   .
Surgicutt fully automated incision making device for bleeding time determination.  ITC 8 Olsen Avenue, Edison, NJ  08820.  732.548.5700.  www.itcmed.com.  A subsidiary of Thoratec Corporation.   The device is a spring loaded cam driven device that provides standardized incisions of 5 mm length and 1 mm depth. This fully automated instrument is used along with blotting paper for bleeding time determinations.
Product Code: SUB50I; Lot No. AK301M. Lot Expiration Date 8/31/2017
6 boxes (Each box contains 50 Surgicutt Devices plus 55 sheets of Blotting Paper).
ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose.
Worldwide Distribution - USA Nationwide in the states of : NE, NH, NC, FL, PA, VA, MI, CA, AL, and TN  and the countries of China, Canada, Saudi Arabia, and Italy.
Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile.   Product Usage:  The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath, a dilator, and a J-tipped guidewire. The kit is designed for safe and easy catheterization and angiography of specific heart chambers and locations.
The TorFlex Transseptal Guiding Sheath Kits are being recalled due to the possibility that the sheath could remove particulate of less than 5 mm from the dilator. The particulate could potentially migrate into a patients bloodstream.
Product was shipped to the following states: AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MO, MS, NC, NE, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI and WY.
Jim Dandy Iron Fortified Quick Grits, 1lb paper box, Labeled in part ''INGREDIENTS: IRON, WHITE CORN GRITS, NIACIN, THIAMIN, MONONITRATE, RIBOFLAVIN, FOLIC ACID. DISTRIBUTED BY: MARTHA WHITE FOODS, INC., P. O. BOX 751030 MEMPHIS, TN 38175***0 13300 11501 5***3067 511 Best If Used By 8-NOV-14***''
The states of Alabama and North Carolina through independent testing notified JM Smucker that aflatoxin levels exceeded FDA specification (<20 ppb). Levels tested ranged from 30 ppb to 207 ppb.
Jim Dandy Enriched Quick Grits, 1lb paper box, Labeled in part INGREDIENTS: WHITE CORN GRITS***NACIN, THIAMIN, MONONITRATE, RIBOFLAVIN, FOLIC ACID. DISTRIBUTED BY: MARTHA WHITE FOODS, INC., P. O. BOX 751030 MEMPHIS, TN 38175***0 13300 12107 8***3143 511 BEST IF USED BY: 23-JAN-14***
Martha White SELF-RISING Corn Meal Bolted White Enriched Hot Rize Net Wt 5 lb (2.26 kg) Paper bag, Mfg Code 3127 511 BEST IF USED BY: 7-Jan-14,  Product labeled in part, INGREDIENTS: ENRICHED BOLTED WHITE CORN MEAL***BAKING POWDER***SALT***DISTRIBUTED BY: MARTHA WHITE FOODS, INC. P.O. BOX 751030, MEMPHIS, TN 38175***013300 18701 2
Gladiola White Cornbread Mix, Net Wt 6 oz (170g) Laminated Pouch Mfg Code 3101 501 BEST IF USED BY: 11 APR 14 Product labeled in part, INGREDIENTS: ENRICHED DEGERMINATED WHITE CORN MEAL, AND ENRICHED BLEACHED FLOUR***PARTIALLY DEHYDROGENATED SOYBEAN OIL, DEXTROSE, BAKING POWDER***MAY CONTAIN***DISTRIBUTED BY: MARTHA WHITE FOODS, INC. P.O. BOX 751030, MEMPHIS, TN 38175***0 13300 54133 3
Martha White Buttermilk Cornbread & Muffin Mix NET WT 6 OZ (170g) Laminated Pouch Mfg Code 3105 501 BEST IF USED BY: 15 APR 14 Product labeled in part INGREDIENTS: ENRICHED DEGERMINATED WHITE CORN MEAL, WHEAT FLOUR*** PARTIALLY DEHYDROGENATED SOYBEAN OIL, DEXTROSE, BAKING POWDER***MAY CONTAIN***DISTRIBUTED BY: MARTHA WHITE FOODS, INC. P.O. BOX 751030, MEMPHIS, TN 38175***0 13300 51701 7
Martha White COTTON COUNTRY CORNBREAD BUTTERMILK CORNBREAD MIX NET WT 6 OZ (170g) Laminated Pouch Mfg Code 3106 501 BEST IF USED BY: 16 APR 14 & Mfg Code 3107 501 BEST IF USED BY: 17 APR 14 Product labeled in part, SINGREDIENTS: ENRICHED DEGERMINATED WHITE CORN MEAL, AND ENRICHED BLEACHED FLOUR***PARTIALLY DEHYDROGENATED SOYBEAN OIL, DEXTROSE, BAKING POWDER***MAY CONTAIN***DISTRIBUTED BY: MARTHA WHITE FOODS, INC. P.O. BOX 751030, MEMPHIS, TN 38175***0 13300 53101 3
3106 501 BEST IF USED BY: 16 APR 14 & 3107 501 BEST IF USED BY: 17 APR 14
Martha White SELF-RISING BUTTERMILK CORN MEAL MIX White-Enriched Hot Rize NET WT 32 OZ (2 LB) 907g Paper Bag Mfg Code 3151 511 BEST IF USED BY: 31 JAN 14 Product labeled in part, INGREDIENTS: ENRICHED WHITE CORN MEAL, WHEAT FLOUR AND DEGERMINATED WHITE CORN MEAL***BAKING POWDER***BUTTERMILK; SALT.***CONTAINS: MILK AND WHEAT INGREDIENTS***DISTRIBUTED BY: MARTHA WHITE FOODS, INC. P.O. BOX 751030, MEMPHIS, TN 38175***0 13300 18301 4
WHITE LILY ENRICHED WHITE Cornmeal MIX SELF-RISING NET WT 32 OZ (2 LB) 907g Paper Bag Mfg Code 3135 511 BEST IF USED BY: 15-JAN-14 Product labeled in part, INGREDIENTS: ENRICHED WHITE CORN MEAL, WHEAT FLOUR AND DEGERMINATED WHITE CORN MEAL***BAKING POWDER***SALT***CONTAINS: WHEAT INGREDIENTS MAY CONTAIN MILK INGREDIENTS***DISTRIBUTED BY: THE WHITE LILY FOODS COMPANY 4740 BURBANK ROAD, MEMPHIS, TN 38118***0 13300 02281 7
Martha White Buttermilk Cornmeal Self-Rising, White, Enriched NET WT 5 LB (2.26kg)  Paper Bag Mfg Code 3152 511 BEST IF USED BY: 1-Feb-14; White Lily Buttermilk Cornmeal Self-Rising, White, Enriched NET WT 32 OZ (2 lb) 907g Paper Bag Mfg Code 3157 511 BEST IF USED BY: 6-Feb-14; Martha White Buttermilk Cornmeal Self-Rising, White, Enriched NET WT 32 OZ (2 lb) 907g Paper Bag Mfg Code 3191 511 BEST IF USED BY: 10-Mar-14 Product labeled in part, INGREDIENTS: ENRICHED WHITE CORN MEAL, WHEAT FLOUR AND DEGERMINATED WHITE CORN MEAL***BAKING POWDER***SALT***CONTAINS: MILK AND WHEAT INGREDIENTS***DISTRIBUTED BY: MARTHA WHITE FOODS INC. P.O. BOX 751030, MEMPHIS, TN 38175***0 13300 18601 5
3152 511 BEST IF USED BY: 1-Feb-14; 3157 511 BEST IF USED BY: 6-Feb-14;  3191 511 BEST IF USED BY: 10-Mar-14
7184 cases-8 units per case; 1497 cases-12 units per case; 4773 cases-12 units per case
Martha White Corn Meal Plain, White, Enriched NET WT  32 OZ (2 LB) 907g  Paper Bag Mfg Code 3193 511 BEST IF USED BY: 12-Mar-14 Product labeled in part, INGREDIENTS: WHITE CORN MEAL, NIACIN, IRON, THIAMIN MONONITRATE, RIBOFLAVIN, FOLIC ACID*** MAY CONTAIN MILK AND WHEAT INGREDIENTS ***DISTRIBUTED BY: MARTHA WHITE FOODS, INC. P.O. BOX 751030, MEMPHIS, TN 38175***0 13300 13501 3
White Lily Corn Meal Self-Rising, White, Enriched NET WT 5 lb (2.26kg)  Paper Bag Mfg Code 3193 511 BEST IF USED BY: 12-Mar-14 Product labeled in part, INGREDIENTS: ENRICHED WHITE CORN MEAL, WHEAT FLOUR AND DEGERMINATED WHITE CORN MEAL***BAKING POWDER***SALT***CONTAINS: WHEAT INGREDIENTS MAY CONTAIN MILK INGREDIENTS***DISTRIBUTED BY: THE WHITE LILY FOODS COMPANY 4740 BURBANK ROAD, MEMPHIS, TN 38118***0 32500 02381 4
Martha White Cotton Country Cornbread, NET WT 6 OZ (170g)  Paper Bag Mfg Code 3107 501 BEST IF USED BY: 17-Apr-14 Product labeled in part, INGREDIENTS: ENRICHED DEGERMINATED WHITE CORN MEAL, ENRICHED BLEACHED FLOUR***PARTIALLY HYDROGENATED SOYBEAN OIL, DEXTROSE, BAKING POWDER*** BUTTERMILK***SALT, SUGAR, SOY LECITHIN, GUAR GUM, NONFAT MILK, MALTODEXTRIN, CELLULOSE GUM, CORN STARCH.*** CONTAINS MILK, SOYBEAN AND WHEAT INGREDIENTS, MAY CONTAIN ALMOND, BRAZIL NUT, CASHEW, EGG, HAZELNUT, MACADAMIA NUT, PECAN, PINE NUT, PISTACHIO NUT AND WALNUT INGREDIENTS. ***DISTRIBUTED BY: MARTHA WHITE FOODS, INC. P.O. BOX 751030, MEMPHIS, TN 38175***0 13300 53101 3
Worldwide distribution: US (nationwide) including Puerto Rico, and countries of: Australia, Belgium, Canada, China, Croatia, Czech Republic, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Macao, Netherlands, New Zealand, Panama, Poland, Portugal Qatar, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Thailand, Trindad and Tobago, Turkey, United Arab Emirates, and United Kingdom. .
UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems   The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as an analyzer for use on a tabletop or with a floor stand. The DxH 600 is available as an analyzer for use on a tabletop only.
Beckman Coulter is initiating a recall for UniCel DxH 800 Coulter Cellular Analysis System (PN 629029) and UniCel DxH 600 Coulter Cellular Analysis System (PN B23858) because the company's internal investigation indicates that specific lots of check valves used in several locations within the DxH 800 and DxH 600 systems may fail. A failure may result in an air or liquid leak at the VCS Waste Chamber or Probe Waste Chamber.
Alaska, Arizona, California, Colorado, Washington, DC, Delaware, Hawaii, Idaho, Illinois, Maryland, Montana, Nebraska, New Mexico, Nevada, Oregon, Pennsylvania, South Dakota, Texas, Virginia, Washington and Wyoming
Angel Food Cake; labeled for retail sale in the following stores:  Safeway, Carrs, Dominicks, Genuardis, Pak N Save, Pavilions, Randalls, Tom Thumb and Vons.  Angel Food Cake  0 lb. 12 oz. (340 g)  Black or White Base with Clear Lid
UPC code 211301010510 with sell by dates of 9/1/13 to 10/1/13.
Incorrect labels were provided to stores that omitted milk and soy.
Holiday Decorated Angel Food Cake; labeled for retail sale in the following stores:  Safeway, Carrs, Dominicks, Genuardis, Pak N Save, Pavilions, Randalls, Tom Thumb and Vons.  Holiday Decorated Angel Food Cake  1 lb. 14 oz. (850 g);  Black or White Base with Clear Lid; frosted/decorated
Angel Food Cups 4 Count; labeled for retail sale in the following stores:  Safeway, Carrs, Dominicks, Genuardis, Pak N Save, Pavilions, Randalls, Tom Thumb and Vons.  Angel Food Cups 4 Count  0 lb. 3 oz. (85g);  Individual cake cups sold in package of 4 items.
Cake Angel Food Loaf: 1) Cake Angel Food Loaf; labeled for retail sale in the following stores:  Safeway, Carrs, Dominicks, Genuardis, Pak N Save, Pavilions, Randalls, Tom Thumb and Vons.  Cake Angel Food Loaf  0 lb. 4 oz. (113 g)  Cake Angel Food Loaf  Individual loaf sold in package of 1 item  2) Cake Angel Food Loaf - 2 count  labeled for retail sale in the following stores:  Safeway, Carrs, Dominicks, Genuardis, Pak N Save, Pavilions, Randalls, Tom Thumb and Vons.  Angel Food Cake Loaf 2 Count  4 oz., and  10 oz. (283 g);  Angel Food Cake Loaf 2 Count  Individual loaf sold in package of 2 items.
Angel Food Cake Fruit Topped; labeled for retail sale in the following stores:  Safeway, Carrs, Dominicks, Genuardis, Pak N Save, Pavilions, Randalls, Tom Thumb and Vons.  Angel Food Cake Fruit Topped  3 lb. 12 oz. (1701 g);  Angel Food Cake Fruit Topped  Black or White Base with Clear Lid; fruit topping.
Incorrect labels were provided to stores that omitted soy flour in ingredient statement.  Soy oil and soy lecithin are listed in the ingredient statement.
Amlodipine Besylate Tablets, USP, 2.5 mg, packaged in a) 90-count bottles (NDC 0378-5208-77) and b) 500-count bottles (NDC 0378-5208-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Amlodipine Besylate and Benazepril HCl Capsules, 2.5 mg/10 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-6895-01
Lamotrigine Tablets, USP, 200 mg, packaged in a) 60-count bottles (NDC 0378-4254-91) and b) 500-count bottles (NDC 0378-4254-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Ciprofloxacin Tablets, USP, 250 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7097-01
Amlodipine Besylate Tablets, USP, 5 mg, packaged in a) 90-count bottles (NDC 0378-5209-77) and b) 500-count bottles (NDC 0378-5209-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/10 mg, packaged in a) 100-count bottles (NDC 0378-6896-01) and b) 500-count bottles (NDC 0378-6896-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/20 mg, packaged in a) 100-count bottles (NDC 0378-6897-01) and b) 500-count bottles (NDC 0378-6897-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.,  NDC 0378-6899-01
Amlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg, in 100 count bottles (NDC# 0378-6898-01) and 500 count bottles (NDC# 0378-6898-05) labeled in part ***Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.***
Amlodipine Besylate and Benazepril HCl Capsules, 10 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-6900-01
Ciprofloxacin Tablets, USP, 500 mg,100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-7098-01
Amlodipine Besylate Tablets, USP 10 mg, packaged in a) 90-count bottles (NDC 0378-5210-77) and b) 500-count bottles (NDC 0378-5210-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Nationwide distribution: USA including Puerto Rico and the states of IL, MT, IN, ND, AZ, MT, KY, NC, OH, MA, MO, VA, CA, NV, TX, WA, NY, GA, SC,MN, WY, PA, ND, UT, NE, CO and MI.
HAMILTON-C2 Ventilator:   Manufactured by Hamilton Medical AG  CH-7402 Bonaduz, Switzerland;  Imported and distributed by Hamilton Medical, Inc. Reno, NV 89502    The HAMILTON C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants and neonates depending on its configuration. Intended areas of use: In the intensive care ward or in the recovery room; During transfer of ventilated patients within the hospital.
Hamilton-C2; Serial numbers from 1000-7100.
Manufacturer defined limits for improperly functioning loudspeakers of the HAMILTON C2 alarm system were exceeded.
Worldwide Distribution-USA (nationwide) and the countries of  Belgium, Canada, Croatia, Germany, Ireland, and Italy.
Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable Tracheostoma Valve II (ATSV II) because the body component of the device is missing from the packaging.  The ATSV II Valve product cannot be used as intended without the product body.
Worldwide Distribution - USA Nationwide and the country of Israel.
OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter Kit)   Product Usage:  The Starter Kit (SKT-UST400) is provided to users as an introduction to the OmniPod Insulin Management System prior to initiating care. It includes the Personal Diabetes Manager (PDM) with two AAA alkaline batteries, a USB cable, a Users Guide, a Soft Carrying Case, a Troubleshooting guide, a Warranty Registration Card, and two Alcohol Pads. The OmniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger. The glucose measurements should not be used for the diagnosis of or screening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared. Abbott FreeStyle test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. Abbott Freestyle Control Solutions are used to verify that the meter and test-strips are working together properly and that the test is performed correctly.
Alcohol Prep Pads contained within the kit are not properly labeled.
OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490)   Product Usage:  The Demonstration Kit (PDK-ZXP490) is an alternate kit provided to potential patients by healthcare professionals for patients to experience what wearing a Pod may feel like prior to purchase. Each Demonstration Kit includes a UST400 brochure, one Alcohol Pad, and a Pod. The OmniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger. The glucose measurements should not be used for the diagnosis of or screening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared. Abbott FreeStyle test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. Abbott Freestyle Control Solutions are used to verify that the meter and test-strips are working together properly and that the test is performed correctly.
Giant Eagle Candy Place Candy Corn Mix in a clear plastic container, net wt. 13 oz, Distributed by Giant Eagle Inc. UPC#3003406974
80 cases  (960 units) George Howe/79 cases (948 units) Giant Eagle
Undeclared  milk, egg, peanut, and soy allergens in Giant Eagle Candy Place Candy Corn Mix
Distribution was made to IA, UT, NV, NE and CA.
Pectinase 3,500 ENDO-PG/G, powder, enzyme, 100 gm. Product 70A
Lot ALI13157-09; re-evaluation date 12/6/2014.   **sample only - not tested    On 10/22/2013 American Laboratories provided CFSAN  a customer distribution list for the Chloramphenicol Contamination.  This spreadsheet listed the base concentrate levels. The data was highlighted: Green, Yellow, Red and Orange.The spreadsheet
The products may be contaminated with Chloramphenicol.
Xylanase 150,000XU, powder, enzyme, 100 gm. Product 13A
Lot ALI13157-11; re-evaluation date 12/6/2014   **sample only - not tested
Xylanase 10,000XU/g, powder, enzyme, 100 gm. Product 45A
Lot ALI13206-05; re-evaluation date 1/25/2015   **sample only - not tested
Xylanase 70,000XU/g, powder, enzyme, 100 gm. Product 71A
Lot ALI13206-06; re-evaluation date 1/25/2015 and Lot # ALI13008-13; re-evaluation date 7/8/2014   **sample only - not tested
NUT 14-500, powder, plant enzyme blend, packaged in 15 kg and 23 kg double poly bags inside fiber box. Product 98A
15 KGS: Lot ALI13212-04; re-evaluation date 1/31/2015 and 23 KGS: Lot # ALI13036-01; re-evaluation date 8/5/2104.   **Lot ALI13212-04 mathmatical analysis tested ''probably < 0.3 ppb in final product''    **Lot ALI13036-01 mathmatical analysis tested  ''probably NOT < 0.3 ppb in final product''
PC Blend 14, powder, enzyme blend, packaged in 9 kg and 25 kg double poly bags inside fiber box. Product 62A
9 KGS: Lot ALI13249-03; re-evaluation date 3/6/2015 and 25 KGS: Lot # ALI13024-02; re-evaluation date 7/24/2014.   **Lots ALI13249-03 and ALI13024-02 mathmatical analysis tested ''probably < 0.3 ppb in final product''    **Lot ALI13036-01 mathmatical analysis tested  ''probably NOT < 0.3 ppb in final product''
Ultra Blend 102, powder, enzyme blend, packaged in 25 kg double poly bags inside fiber box. Product 73B, SI Item # 10678.
Lot # ALI13053-05; re-evaluation date 8/22/2104   **Lot ALI13053-05 mathmatical analysis tested  ''VERY probable NOT < 0.3 ppb in final product''
EB 110311-01, powder, enzyme blend, packaged in 5 kg double poly bags inside fiber box. Product 73C
Lot # ALI13200-09, re-evaluation date 1/19/2015; Lot # ALI13140-03, re-evaluation date 11/20/2014; Lot # ALI13071-01, re-evaluation date 9/12/2014 and Lot # ALI13008-01; re-evaluation date 7/8/2014.   **Lot ALI13200-09 mathmatical analysis tested ''probably < 0.3 ppb in final product''    **the other three lots mathmatical analysis tested ''probably NOT < 0.3 ppb in final product''
EB 020812-01, powder, enzyme blend, packaged in 5 kg double poly bags inside fiber box. Product 77C
Lot # ALI13200-08, re-evaluation date 1/19/2015; Lot # ALI13140-02, re-evaluation date 11/20/2014; Lot # ALI13071-02, re-evaluation date 9/12/2014 and Lot # ALI13008-02; re-evaluation date 7/8/2014.   **Lot ALI13200-08 mathmatical analysis tested ''probably < 0.3 ppb in final product''    **the other three lots mathmatical analysis tested ''probably NOT < 0.3 ppb in final product''
Distribution was made both retail and wholesale to AZ, CA, CO, FL, GA, IA, IL, KS, KY, LA, MD, MI, MN, NJ, MN, MO, NC, NE, NH, NY, OH, OR, PA, TX, WA and WI.  Distribution was made to PR.
VIT-RA-TOX Whole Beet Plant Juice, dietary supplement, dry, 400 mg tablet,  packaged in 150 tablets glass, amber bottles. No. 48.  National Distributors: V.E. Irons, Inc, N. Kansas City, MO.    Springreen Whole Beet Plant Juice, dietary supplement, dry, 400 mg tablet,  packaged in 150 tablets glass, amber bottles. No. 88. National Distributors: Springreen Products, Inc, N. Kansas City, MO.    Sonne's Whole Beet Plant Juice, dietary supplement, dry, 400 mg tablet,  packaged in 150 tablets glass, amber bottles.  No. 18.  National Distributors: Sonne's Organic Foods, Inc., N. Kansas City, MO
All three labels have the same lot code: 06-11-15-2
The firm reports a customer found a foreign object in the product.
Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial per carton, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Schiffgraben 23, 38690 Vienenburg, Germany; Distributed by: West-Ward Pharmaceutical Corp., Eatontown, NJ  07724 USA, NDC 0143-9702-01.
Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.
Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial per carton, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Schiffgraben 23, 38690 Vienenburg, Germany; Distributed by: West-Ward Pharmaceutical Corp., Eatontown, NJ  07724 USA, NDC 0143-9701-01.
Stryker Instruments Div. of Stryker Corporation
Nationwide Distribution including the states of AR, AZ, CA, CO, FL, GA, IL, KS, MS, ND, and NE.
Dekompressor Percutaneous Discectomy Probe.   The Dekompressor is a single use disposable discectomy probe that passes through and works in conjunction with an introducer cannula to remove intervertebral disc nucleus pulposus material.
Stryker has identified a potential for the auger and/or cannula to fracture when the Dekompressor is used contrary to the warnings in the Instructions For Use (IFU). Specifically, manually bending the cannula can weaken the device and may result in a fracture of the auger and/or cannula. This could result in the need for additional medical intervention to remove the broken piece, pain or loss of mobility. There have been no deaths or serious adverse events.
Nationwide distribution: US including states of: CA, GA, IL, KY, LA, MI, MD, NY, OR, TX, VA and Puerto Rico.
Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite; 4mm telescope 30 25 / 12: only for continuous irrigation sheath 24,5 Fr.; LOT 426111; 2011/06; 2016/06; STERILE; RICHARD WOLF;    Cartons of 3 units labeled in part: REF 46300223; Vaporization electrode, sterile; 4mm telescope 30/25/12; only for continuous irrigation sheath 24,5 Fr.; Lot 426111; 2011/06; 2016/06; STERILE; RICHARD WOLF    S(a)line Resectoscopes are used for endoscopically controlled removal (ablation) of tissue using 0.9% NaCl solution (saline) as the irrigation medium. It can also be used for monopolar resection if necessary.
*** Individual Units ***  Product Code: 4630022;   Lot: 426111;   Expiration Date: 2016/06;   *** Cartons ***   Product Code: 4630023;   Lot: 426111;   Expiration Date: 2016/06;
Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporization electrode was packaged in a 4630022 pouch.
Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufactured in India by Sandoz Private Ltd, for Sandoz Inc, Princeton, NJ 08540, NDC 0781-5780-92
Cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended Release Tablets 2 mg due to the potential presence of carryover coming from the previously manufactured product, mycophenolate mofetil.
Worldwide Distribution - USA including PA and Internationally to Canada.
Aquatec Ocean VIP, Aquatec Ocean Dual-VIP, Aquatec Ocean E-VIP mobile shower and toilet commode with tilting function.    Mobile shower and toilet commode with tilting function
The snap-on fixtures of the backrest cushion on the Mobile Shower and Toilet Commode Aquatec Ocean VIP and Ocean Dual VIP do not withstand a required pull out force of 500 N, when the product is used in a reclined position and or tilted position. This may result in the snap-on fixture coming unlatched.
Worldwide Distribution - USA including WA, NY, VA, TN, SC, TX, CA, CO, MA, WI, MD, AL, ND, and Puerto Rico and Internationally to Italy, Finland, Germany, Sweden, and Great Britain.
S5 Heart-lung machine, Stockert S5 System.  Catalogue No: 48-30/40/50-00.   The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less.
Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.
Worldwide Distribution in the states of: Alabama, Connecticut, Indiana, Michigan, North Carolina, South Carolina, Alaska, Delaware, Kansas, Minnesota, Ohio, Tennessee, Arizona, Florida, Kentucky, Mississipp,i Oklahoma, Texas, Arkansas, Georgia, Louisiana, Nebraska, Oregon, Virginia, California, Idaho, Maryland, Nevada, Pennsylvania, Washington, Colorado, Illinois, Massachusetts, New Jersey, Rhode Island, and West Virginia. and the countries of: Argentina, France, Malaysia, Spain, Australia, Georgia, Martinique, Sweden, Belgium, Germany, Mexico, Switzerland, Brazil, Greece, Netherland, Taiwan, Chile, Hungary, Panama, Tunisia, China, India, Philippines, United Arab Emirates, Czech Republic, Israel, Poland, United Kingdom, Egypt, Italy, Portugal, Venezuela, Estonia, Kenya, Russia, Finland, Kuwait, and Saudi Arabia.
Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids, or in various kit configurations with one band per kit.   Product Usage:  Intended for use in surgical treatment of morbid obesity
The following product code and lot numbers were affected by this recall: Product Codes: RLZB22 Lot Numbers: ZJKBK6, ZJLBBR, ZJLBBT, ZJLBBV, ZJMBB5, ZJMBCG, ZJMBCH, ZJMBCJ, ZJMBCK, ZJMBCL, ZJMBJC, ZJMBJD, ZJMBJF, ZJPBD1, ZJPBD2, ZJPBFT, ZJPBFV, ZKBBCC, ZKBBCD, ZKBBCF, ZKBBCG, ZKBBGC, ZKBBGD, ZKBBGJ, ZKBBJN, ZKBBNV, ZKBBNW, ZKBBNY, ZKCBBK, ZKCBDD, ZKCBJJ, ZKMBK4, ZKMBKP, ZKNBBB, ZKNBCL, ZLBBCH, ZLBBFJ, ZLBBFL, ZLCBCB, ZLCBD8, ZLDBCZ, ZLDBDM, ZLDBDV, ZLFBF7, ZLFBFB, ZLLBCR, ZLLBFT, ZLMBCH, ZLMBWD, ZLNBBF, ZLNBGZ, ZMCBDH, ZMDBCH, ZMFBC4, ZMGBBF, ZMGBC1, ZMHBBW, ZMJBHV, ZMKBBH, ZMLBCJ, ZMNBCK, ZNBBD2, ZNFBCC, ZNHBCM, and ZNLBB4.     Product Codes: RLZB22D1  Lot Numbers: G4TA93, G4TC3R, G4TD5R, G4TF1X, G4TG22, G4TK21, G4TL1D, G4TM3L, G4TM84, G4TP0W, G4TT4D, G4TU2V, G4TV3T, G4TW6D, G4U17U, G4U75W, G4U795, G4UD6T, G4UF6Y, G4UG4E, G4UH49, G4UH4K, H43A3N, H43C8P, H43E9V, H43J2P, H43N12, H43N42, H43P5U, H43P9C, H43T3F, H43U78, H43V8J, H43X4K, H43Z8Y, H4453N, H44623, H4478W, H44965, H44C9G, H44D8W, H44K3G, H44K9M, H44N0X, H44R1Y, H44R4U, H44T9D, H44V39, H44W6H, H44Y24, H44Z0Y, J4A04D, J4A11V, J4A274, J4A668, J4A81X, J4A96M, J4AC6L, J4AE3P, J4AH2Z, J4AK89, J4AN34, J4AU9R, J4AW1Y, J4C35K, J4C76E, J4CE9V, K4C518, K4CE4L, K4CT8W, K4D17T, and K4D45Y.     Product Codes: RLZB22DG1  Lot Numbers: G4TH90, G4TJ61, G4TP6J, G4TR76, G4TV48, G4TX1V, G4U184, G4U734, G4UD77, G4UF9V, G4UH6P, H43A3P, H43C8R, H43G7Y, H43T3K, H43U7E, H43X1G, H43Z5Y, H44645, H44H9M, H44K2T, H44L44, H44V3A, H44W6G, H44Y25, H44Z0X, H44Z3N, J4A48K, J4AA11, J4AL00, J4AR9K, and K4CE6X .    Product Codes: RLZB22DGT  Lot Numbers: G4U323, J4AY55, and K4C663.     Product Codes: RLZB22DT  Lot Numbers: G4UD92, H44D1Y, J4AY72, and K4C666.     Product Codes: RLZB22T  Lot Numbers: G4RE82
Product codes: RLZB22 - 2,352 units; RLZB22D1 - 968 units; RLZB22DG1 - 327 units; RLZB22DGT - 20 units; RLZB22DT - 48 units; RLZB22T - 0 units
During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.
Worldwide Distribution in the states of: Alabama, Connecticut, Indiana, Michigan, North Carolina, South Carolina, Alaska, Delaware, Kansas, Minnesota, Ohio, Tennessee, Arizona, Florida, Kentucky, Mississipp,i Oklahoma, Texas, Arkansas, Georgia, Louisiana, Nebraska, Oregon, Virginia, California, Idaho, Maryland, Nevada, Pennsylvania, Washington, Colorado, Illinois, Massachusetts, New Jersey, Rhode Island, and West Virginia. and the countries of:  Argentina, France, Malaysia, Spain, Australia, Georgia, Martinique, Sweden, Belgium, Germany, Mexico, Switzerland, Brazil, Greece, Netherland, Taiwan, Chile, Hungary, Panama, Tunisia, China, India, Philippines, United Arab Emirates, Czech Republic, Israel, Poland, United Kingdom, Egypt, Italy, Portugal, Venezuela, Estonia, Kenya, Russia, Finland, Kuwait, and Saudi Arabia.   In addition to the products listed in the Quantity Distributed section above, 1,363 RLZB22 gastric bands in convenience kits were also distributed as follows, according to Band Pak Codes: RLZB22D1 - 968 kits, RLZB22DG1 - 327 kits, RLZB22DGT - 20 kits, and RLZB22DT - 48 kits.
Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids.   Product Usage:  Intended for use in surgical treatment of morbid obesity
The following product code and lot numbers were affected by this recall: Product Codes: 2200-X Lot Numbers:  ZLGBC5, ZLNBCW, ZLNBJC, ZLPBB9, ZMBBBB, ZMCBBC, ZMGBCJ, ZMHBBT, ZMHBCV, ZMLBD0, ZMMBCD, ZMPBBC, ZNCBC6, ZNGBB3, and ZNGBBF.
The following product code and lot numbers were affected by this recall: Product Codes: BD2XV Lot Numbers: ZJMBB4, ZJMBN9, ZJNBBV, ZKDBM6, ZKDBM7, ZKFBDC, ZKGBDY, ZKHBBJ, ZKHBCR, ZKHBFG, ZKNBCK, ZKNBHC, ZLBBFK, ZLDBB8, ZLFBBC, ZLFBGG, ZLGBFV, ZLGBG5 , ZLJBCL, ZLMBBD, ZLMBYF, ZLNBCH, ZMBBGJ, ZMCBDL, ZMFBCT, ZMGBDF, ZMKBCG, ZNBBBB, and ZNCBBB.
Worldwide Distribution-USA (nationwide) and the country of  Canada.
pH 7.0 Buffer Solution Pint and Quart Bottles, Part Number 02.0030 for Pints and 02.0031 for Quarts. Packaged in Plastic Bottles.  Can be sold individually or in cartons with 6 bottles per box (for quart bottles only).   Used in the hemodialysis setting to calibrate pH meters.
Mesa Laboratories, Inc. is recalling certain lots of pH 7.0 Buffer Solution due to mold growth.
The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per transducer) ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature and to deliver solutions into the pulmonary arteries.   The EkoSonic Endovascular System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature and the infusion of solutions into the pulmonary arteries. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non sterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.
PT3B-783.    PT3B represents the model number. Adding 783 creates the serial number.
The EkoSonic Control Unit is recalled because it had the incorrect power entry module installed.  It is missing an AC filter to reduce the noise and electrical interference.
Custom made gift boxes containing:  HONEY ROASTED PEANUTS, Net Wt. 11 oz. (311G), Dist.By: Dutch Valley Food Distributors, Inc. Myerstown, PA 10787, UPC 8 77245 00143 3
Honey Roasted Peanuts, packaged in custom gift boxes, contained milk and wheat which were not declared on the label.
Worldwide Distribution - USA including Puerto Rico and the countries of  Australia, Austria, Argentina, Belgium, Bulgaria, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, India, Indonesia, Ireland, Israel, Japan, Kuwait, Mexico, Netherlands, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay and Venezuela.
Patient Cart used in conjunction with the da Vinci S surgical and SI System.   Intuitive Surgical  1266 Kifer Road  Sunnyvale, CA 94086    The Patient Side Cart (PSC) is a robotic platform used for da Vinci Surgery. It is the operative component for both da Vinci systems and its primary function is to support he instrument arms and camera arm. It uses remote center technology. The remote center is a fixed point in space around which the Patient Cart arms move. Remote center technology enables the system to maneuver instruments and endoscopes in the surgical site while exerting minimal force on the patient body wall. The Patient Cart works in the sterile field, assisting the Surgeon Console operator by exchanging instruments and endoscopes, and by performing other patient-side activities. To help ensure patient safety, the action of the Patient Cart operator take precedence over actions of the Surgeon Console operator.
Increased number of complaints regarding fluid entering the patient card base of the da Vinci S and SI systems.
Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile.  Mfg in Medtronic Ireland, Galaway, Ireland. Distributed by: Medtronic Inc.  Minneapolis, MN.    Indicated for improving coronary luminal diameters in patients.
Model: RSINT30034UX;  Customer Facing Number: RSIST30034UX.  Expiration date: 25 May 2014.
A small number of units in lot number 0006573585 of the Resolute Integrity Zotarolimus-Eluting Coronary Sten System may contain a compliance chart incorrectly referencing a 2.25 mm diameter instead of the correct 3.0mm.
USA Nationwide Distribution in the states of: AZ, NC, IA, PA, OH, MD, and TN.
GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168.   Product Usage:  orthopaedic
Swapped product.  Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.
GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188.   Product Usage:  orthopaedic
Serene Science/Source Naturals brand GABA (Gamma-Aminobutyric Acid), CALM MIND, A dietary supplement,  45 Tablets, Item #: SN0237;  90 Tablets, Item #: SN0240;  180 Tablets, Item #: SN0268;    Product label states, ''manufactured for Source Naturals, Inc., P.O. Box 2118, Santa Cruz, CA 95062''; and distributed by Threshold Enterprises, Ltd, Scotts Valley, CA;     The product is actually manufactured by a Contract Manufacturer:  Abco Laboratories, Inc., 2450 S. Watney Way, Fairfield, CA 94533
Item #: SN0237 - 45 Count, Lot Numbers: FG-40244, FG-40421, FG-40679;   Item #: SN0240 - 90 Count, Lot Numbers: FG-40245, FG-40422, FG-40680;    Item #: SN0268 -180 Count Lot Number: FG-40681;    All packages have BEST BY DATE 3/21/17
The firm found small piece of metal fragment in one tablet during its inspection process.
Worldwide Distribution - USA (nationwide) and Internationally tAustralia, Austria, Belgium, Brazil, *Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, India, Israel, Italy, Mexico, Monaco, Netherlands, Norway, Pakistan, Panama, Qatar, Romania, Russian Fed., Saudi Arabia, Singapore, South Korea, Sweden, Switzerland, Taiwan, and Turkey.
da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000;  Y1903 Illuminator (Illuminator + Lamp Module);   Y1902 Replacement Lamp Modules.    Intuitive Surgical, Sunnyvale, CA.    As a component of the IS3000 da Vinci Si Surgical System, the 3DHD Vision System provides a high resolution image for the surgeon (at the 3D viewer) and the patient-side assistant (at the touchscreen). The 3DHD endoscope assembly (endoscope and camera head) can be used manually (that is, handheld, as with a traditional endoscopy cart) or can be mounted on the camera arm to assist with preoperative exploration. Also integrated in the Vision System Cart is the Illuminator. The illuminator has a single light source attached to the endoscopy assembly by the light guide cable. It provides illumination inside the body for vision of the surgical field. The Illuminator monitors the life left on the lamp module and notifies the customer when replacement is recommended.
Standalone: 161 units; With Vision Starter Kit: 240 units; With IS3000 Vision Cart: 283 units
Intuitive has identified that the metalized coating on the IS3000 HD lamp module may be incompatible with the illuminator control board, leading to an erroneous red Preventive Maintenance Message that shows up on monitors.
KCB Pista Khatie KCB Bakery Products Corp.  56-28 56th Street, Maspeth, NY 11378  Tel: (718) 786-9463 Fax (718) 361-0171  www.kbcusa.com    a) Net Wt. 30 OZ (850 G)    b) Net Wt. 13 OZ (369 G)    Packaged in a plastic clam shell container with stick-on labels.
Use By Date: 16 May 14; 13 oz. package UPC Code: 12042 00129; 30 oz. package UPC Code: 12042 00296
24 cases x 12 plastic clam shell boxes; 15 cases x  13 clam shel boxes
The firm's Pista Khatie cookies with use by date 16 May 14 were tested by the Canadian Food Inspection Agency (CFIA) and found to contain 70 ppm of undeclared egg allergen. The label for this product states that it does not contain eggs.
ORBIT PT.   The ORBIT PT works in conjunction with an TRUMPF mobile operating table to automate the patient transport process.
An odor and smoke developed - The cause was determined to be a power supply unit sitting in the controller column.
US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide Enabled REF A700244, Rx only, Sterile EO.    The catheters are intended for use with a compatible external irrigation pump and the IBI-15500T9-CP RF Generator at a maximum of 50 Watts. MediGuide Enabled Ablation catheters are used with the MediGuide Technology to enable real-time tip positioning and navigation and in conjunction the the EnSite Velocity System. The MediGuide Technology is indicated for use as an adjunct to fluoroscopy.
Catalog Number A700244 Batch Number 4113241. Catalog Number A700240 Batch Number 4113242.
St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batches of Coolpath Duo Ablation Catheter MediGuide Enabled products and Safire Duo Ablation Catheter MediGuide Enabled.  These units were inadvertently shipped with the incorrect version of the Instructions for Use (IFU).
Dual Action Cleanse by Cellular Research Formulas, 60 ct, Item AN027370, UPC 7 10363 27370 5, Item AN056592HFS, UPC 7 10363 56592 3; Item DR056439, UPC 7 10363 57369 0.
Irwin Naturals is recalling Daily Digestive Enzymes and Dual Action Cleanse because they may possibly be contaminated with chloramphenicol.
Dual Action Cleanse by Cellular Research Formulas with Green Tea Bonus 60 ct, Item AN056906E, UPC Code: 7 10363 56906 8
Irwin Naturals Daily Digestive Enzymes 45 ct, Item IN057552, UPC Code: 7 10363 57552 6
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL single patient infusion vial packaged in 5 Units x 20 mL per carton, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
Presence of Particulate Matter: Visible particles embedded in the glass identified during a retain sample inspection.
Nationwide Distribution - all states in continental USA including DC but not OK or RI.   OUS: Australia,  Austria,  Belgium,  Brazil, Canada,  China,  Denmark,  Finland, France,  Germany,  Honduras,  Hong Kong,  Iceland,  Ireland,  Italy,  Korea, Netherlands,  New Zealand,  Norway,  Pakistan, Poland, Portugal, Qatar, r Saudi Arabia,  Serbia,  Singapore, Slovenia, South Africa,Spain , Sweden, Switzerland, Thailand, Turkey, Ukraine.
VitreaCore software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3 (except 6.3.1 ), 6.4 (except 6.4.4 and 6.4.5), as  well as their upgrades, and 6.5.     The VitreaCore (ViTALConnect) system is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital Images acquired from a variety of imaging devices including: CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. The VitreaCore (ViTALConnect) is not meant for primary Image Interpretation In mammography.
Vital Images, Inc. has found an issue in VitreaCore software though internal testing.  There is a potential for incorrect and possibly reversed image orientation for certain snapshots taken in VitreaCore software versions 6.0, 6.1, 6.2, 6.3 (except 6.3.1), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5.