Platelets Pheresis Leukocytes Reduced Irradiated
Blood products, labeled leukoreduced which did not meet the requirements for leukoreduced products, were distributed.
Blood Bank of San Bernardino and Riverside Counties
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Blood and Blood Products for Reprocessing
Blood products, collected from a donor who was taking the drug Methotrexate, were distributed.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood products, which were out of controlled storage temperatures, were distributed.
Blood product, with positive bacterial detection testing, was distributed.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Blood products, collected from a donor who reported receiving a body piercing within 12 months of donating, were distributed.
Donor Screening/Donor gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked
Worldwide Distribution-USA (nationwide) and the countries of  Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand,  and United Kingdom.
Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting with 0011420, 11460 and 11461.
Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.
HERBERT MINI BONE SCREW 2 and HERBERT/WHIPPLE C ANN BONE. Items starting with 0011500 and 0011520.
FREE-LOCK LAG SCREW, 12.7, FREE-LOCK LAG SCREW, 15.8, FREE-LOCK SUPRACOND TUBE and FREE-LOCK TUBE & SCP PLAT. Items starting with codes 0011810 and 0011811.
Item codes starting with 001930   LAG SCR 12.7D X 55MM SHOR up to 155 MM, LAG SCR 12.7D X 55 MM SHO up to 100MM,  LAG SCR 12.7D X 55MM STAN up to 155 MM, LAG SCR 15.8D X 55MM LARG up to 155 MM
VERSA-FX II KEYLESS TUBE, VERSA-FX II KEYLESS SHORT, VERSA-FX II SHORT TUBE PL, VERSA-FX II STD TUBE PLAT and VERSA-FX II SUPRACONDYLR    Item codes starting with 0011930, 0011931 and 0011941
VERSA-FX KEYLESS 90D X 8 and X 11, VERSA-FX KEYLESS 95D X 8, X 11, and X 14, VERSA-FX KEYLESS 140D X 4 and X 5, VERSA-FX KEYLESS 135D X 4 and X 5, VERSA-FX SHORT TUBE, 130D, 135D and 140D, VERSA-FX STANDARD TUBE, 1 and VERSA-FX SPRCNDLR TUBE, 9   Item codes starting with 001980, 001981, 0011990 and 0011991
M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM. Item codes starting with 0022400
RECON SCREW LG 5.5MM DIA  and M/DN FEM IM NAIL 8MM DIA  to 16 MM DIA. Item codes starting with 0022520, 0022521, 002522, 0022523, 0022524 and 0022525.
INTERLOCKING IM SCREW SML, MED and LRG; M/DN TIBIAL I/M NAIL 6 MM to 15 MM.   Some items starting with codes 0022530, 0022531, 002532, 0022533, 0022534
INTERLOCKING IM SCREW 4.5 and INTERLOCKING IM SCREW LG   Some items starting with codes 0022530
M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541, 002542 and 0022543.
ITST ANTI-ROTATION SCREW  and FEM IM NAIL (10MM, 11 MM, 12 MM, 13 MM, 14 MM and 15 MM) DIA X  (18, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48 and 50)
ONE-PIECE LAG SCREW 11MM. Item codes starting with 00225900.
DISTAL MEDIAL FEMORAL CON, DISTAL POSTERIOR/LATERAL, DISTAL SMALL VOLAR RADIUS, PROXIMAL DORSAL ULNA PLT, and PROXIMAL MEDIAL TIBIAL 4.
MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS 3, 4, 5 and 6.
MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS sizes 3, 4, 5, and 6, and Mod Austin Moore Fem Stem
MODULAR AUSTIN MOORE FENE. Item codes starting with 45502001, 455503001 and 455504001
NEXGEN OSTEOTOMY CORT BON. Item codes starting with 0052500
I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3 and 4), MGII KNEE SLF-TAP BONE ST
NEXGEN MIS TIBIA PLATE PR NEXGEN TAPER PLUG          NEXGEN PRECOAT PEG TIB PL  NEXGEN MICRO ALL-POLY PAT  NEXGEN ALL-POLY PATELLA,   NEXGEN PRECOAT STEMMED TI  NEXGEN OPTION STEMMED TIB  NEXGEN STRAIGHT STEM EXT   NEXGEN SHARP FLUTED STEM   NEXGEN FLUTED STEM EXT, 1  NEXGEN FLUTED STEM EXT, 2  NEXGEN CEMENTED STEM EXT
MODULAR CUP NEUTRAL LINER MODULAR CUP 10 DEGREE LIN  MODULAR CUP 20 DEGREE LIN  MODULAR CUP 7MM OFFSET LI
TRILOGY ACET SHELL 36MM O TRILOGY ACET SHELL 38MM O  TRILOGY ACET SHELL 40MM O  TRILOGY ACET SHELL 42MM O  TRILOGY ACET SHELL 44MM O  TRILOGY ACET SHELL 46MM O  TRILOGY ACET SHELL 48MM O  TRILOGY ACET SHELL 50MM O  TRILOGY ACET SHELL 52MM O  TRILOGY ACET SHELL 54MM O  TRILOGY ACET SHELL 56MM O  TRILOGY ACET SHELL 58MM O  TRILOGY ACET SHELL 60MM O  TRILOGY ACET SHELL 62MM O  TRILOGY ACET SHELL 64MM O  TRILOGY ACET SHELL 66MM O  TRILOGY ACET SHELL 68MM O  TRILOGY ACET SHELL 70MM O  TRILOGY ACET SHELL 72MM O  TRILOGY ACET SHELL 74MM O  TRILOGY ACET SHELL 76MM O  TRILOGY ACET SHELL 78MM O  TRILOGY ACET SHELL 80MM O  BONE SCREW 4.5X15 SELF-TA  BONE SCREW 4.5X20 SELF-TA  BONE SCREW 4.5X25 SELF-TA  BONE SCREW 4.5X30 SELF-TA  BONE SCREW 4.5X35 SELF-TA  BONE SCREW 4.5X40 SELF-TA  BONE SCREW 4.5X50 SELF-TA  BONE SCREW 4.5X60 SELF-TA  BONE SCREW 6.5X15 SELF-TA  BONE SCREW 6.5X20 SELF-TA  BONE SCREW 6.5X25 SELF-TA  BONE SCREW 6.5X30 SELF-TA  BONE SCREW 6.5X35 SELF-TA  BONE SCREW 6.5X40 SELF-TA  BONE SCREW 6.5X50 SELF-TA  BONE SCREW 6.5X60 SELF-TA  BONE SCREW 6.5X70 SELF-TA  BONE SCREW 6.5X80 SELF-TA
12/14 UNIPOLAR FEMORAL HE VERSYS CEM LD/FX SZ 11X12  VERSYS CEM LD/FX SZ 12X12  VERSYS CEM LD/FX SZ 14X13  VERSYS CEM LD/FX SZ 16X14  VERSYS CEM LD/FX ST 18X15  VERSYS PRESS FIT LD/FX ST  VERSYS PRESS FIT LD/FX SZ  VERSYS ADVOCATE CEMENTED   VERSYS ADVOCATE V-LIGN CE  VERSYS CEMENTED FEM STEM   VERSYS CT FEM STEM 11X120  VERSYS CT FEM STEM 12X125  VERSYS CT FEM STEM 13X130  VERSYS CT FEM STEM 14X135  VERSYS CT FEM STEM 15X140  VERSYS CT FEM STEM 16X145  VERSYS CT FEM STEM 17X150  VERSYS CEM/REV/CALCAR 13X  VERSYS CEM/REV/CALCAR 15X  VERSYS CEM/REV/CALCAR 17X  VERSYS CEM/REV/CALCAR 19X
12/14 COCR FEMORAL HEAD (2, 3 and 4); 12/14 FEMORAL HEAD (+7X28M and 7X32M)
6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE
MODULAR AUSTIN MOORE SOLI and MOORE HIP PROS REG SOLID
CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)
HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE S
PERI SCR. 3.5MM X 10MM    PERI SCR. 3.5MM X 12MM     PERI SCR. 3.5MM X 14MM     PERI SCR 3.5MM X 44MM STE  PERI SCR. 3.5MM X 65MM     PERI. SCR 4.0MM X24MM      PERI. SCR 4.0MM X40MM      PERI SCR. 4.0MMX14MM FULL  PERI SCR. 4.0MMX32MM FULL  PERI SCR. 4.0MMX38MM FULL  3.5MM CORT SCR X 10MM      3.5MM CORT SCR X 12MM      3.5MM CORT SCR X 14MM      3.5MM CORT SCR X 16MM      3.5MM CORT SCR X 18MM      3.5MM CORT SCR X 20MM      3.5MM CORT SCR X 22MM      3.5MM CORT SCR X 24MM      3.5MM CORT SCR X 26MM      3.5MM CORT SCR X 28MM      3.5MM CORT SCR X 30MM      3.5MM CORT SCR X 32MM      3.5MM CORT SCR X 34MM      3.5MM CORT SCR X 36MM      3.5MM CORT SCR X 38MM      3.5MM CORT SCR X 40MM      3.5MM CORT SCR X 42MM      3.5MM CORT SCR X 44MM      3.5MM CORT SCR X 46MM      3.5MM CORT SCR X 48MM      3.5MM CORT SCR X 50MM      3.5MM CORT SCR X 52MM      3.5MM CORT SCR X 54MM      3.5MM CORT SCR X 56MM      3.5MM CORT SCR X 58MM      3.5MM CORT SCR X 60MM      3.5MM CORT SCR X 65MM      3.5MM CORT SCR X 70MM      3.5MM CORT SCR X 75MM      3.5MM CORT SCR X 80MM      3.5MM CORT SCR X 85MM      3.5MM CORT SCR X 90MM      3.5MM CORT SCR X 100MM     3.5MM CORT SCR X 105MM     3.5MM CORT SCR X 110MM     CANC SCR 4.0MM X 10MM      CANC SCR 4.0MM X 10MM FUL  CANC SCR 4.0MM X 12MM      CANC SCR 4.0MM X 12MM FUL  CANC SCR 4.0MM X 14MM      CANC SCR 4.0MM X 14MM FUL  CANC SCR 4.0MM X 16MM      CANC SCR 4.0MM X 16MM FUL  CANC SCR 4.0MM X 18MM      CANC SCR 4.0MM X 18MM FUL  CANC SCR 4.0MM X 20MM      CANC SCR 4.0MM X 20MM FUL  CANC SCR 4.0MM X 22MM      CANC SCR 4.0MM X 22MM FUL  CANC SCR 4.0MM X 24MM      CANC SCR 4.0MM X 24MM FUL  CANC SCR 4.0MM X 26MM      CANC SCR 4.0MM X 26MM FUL  CANC SCR 4.0MM X 28MM      CANC SCR 4.0MM X 28MM FUL  CANC SCR 4.0MM X 30MM      CANC SCR 4.0MM X 30MM FUL  CANC SCR 4.0MM X 32MM      CANC SCR 4.0MM X 32MM FUL  CANC SCR 4.0MM X 34MM      CANC SCR 4.0MM X 34MM FUL  CANC SCR 4.0MM X 36MM      CANC SCR 4.0MM X 36MM FUL  CANC SCR 4.0MM X 38MM      CANC SCR 4.0MM X 38MM FUL  CANC SCR 4.0MM X 40MM
2.7 X 6 CORT SCREW/SELFTA 2.7 X 7 CORT SCREW/SELFTA  2.7 X 8 CORT SCREW/SELFTA  2.7 X 9 CORT SCREW/SELFTA  2.7 X 10 CORT SCREW/SELFT  2.7 X 12 CORT SCREW/SELFT  2.7 X 14 CORT SCREW/SELFT  2.7 X 16 CORT SCREW/SELFT  2.7 X 18 CORT SCREW/SELFT  2.7 X 20 CORT SCREW/SELFT  2.7 X 22 CORT SCREW/SELFT  2.7 X 24 CORT SCREW/SELFT  2.7 X 26 CORT SCREW/SELFT  2.7 X 28 CORT SCREW/SELFT  2.7 X 30 CORT SCREW/SELFT  2.7 X 32 CORT SCREW/SELFT  2.7 X 34 CORT SCREW/SELFT  2.7 X 36 CORT SCREW/SELFT  2.7 X 38 CORT SCREW/SELFT  2.7 X 40 CORT SCREW/SELFT  2.7 X 42 CORT SCREW/SELFT  2.7 X 44 CORT SCREW/SELFT  2.7 X 45 CORT SCREW/SELFT  2.7 X 46 CORT SCREW/SELFT  2.7 X 48 CORT SCREW/SELFT  2.7 X 50 CORT SCREW/SELFT  4.0 X 20 CANC SCREW/SELFT
X 65 PART THD CANC SC 4.0 X 70 CANCELL. SCREW    4.0 X 70 PART THD CANC SC  4.0 X 75 CANCELL. SCREW    4.0 X 80 CANCELL. SCREW    4.5 X 16 CORT SCREW SELF   4.5 X 22 CORT SCREW SELF   4.5 X 24 CORT SCREW SELF   4.5 X 26 CORT SCREW SELF   4.5 X 28 CORT SCREW SELF   4.5 X 30 CORT SCREW SELF   4.5X30 MALLEOLAR SCREW     4.5 X 32 CORT SCREW SELF   4.5 X 34 CORT SCREW SELF   4.5 X 36 CORT SCREW SELF   4.5 X 38 CORT SCREW SELF   4.5 X 40 CORT SCREW SELF   4.5X40 MALLEOLAR SCREW     4.5 X 42 CORT SCREW SELF   4.5 X 44 CORT SCREW SELF   4.5 X 46 CORT SCREW SELF   4.5 X 48 CORT SCREW SELF   4.5 X 50 CORT SCREW SELF   4.5 X 52 CORT SCREW SELF   4.5 X 54 CORT SCREW SELF   4.5 X 56 CORT SCREW SELF   4.5 X 58 CORT SCREW SELF   4.5 X 60 CORT SCREW SELF   4.5 X 62 CORT SCREW SELF   4.5 X 64 CORT SCREW SELF   4.5 X 70 CORT SCREW SELF   6.5 X 50 CANC SCREW, 32MM  6.5 X 55 CANC SCREW, FULL  6.5 X 60 CANC SCREW, FULL
3.5 COMP PLT, 4 HOLE      3.5 COMP PLT, 5 HOLE       3.5 COMP PLT, 6 HOLE       3.5 COMP PLT, 8 HOLE       3.5 COMP PLT, 9 HOLE       3.5 COMP PLT, 10 HOLE
3.5 X 10 CORT SCREW SELFT 3.5 X 12 CORT SCREW SELFT  3.5 X 14 CORT SCREW SELFT  3.5 X 16 CORT SCREW SELFT  3.5 X 18 CORT SCREW SELFT  3.5 X 20 CORT SCREW SELFT  3.5 X 22 CORT SCREW SELFT  3.5 X 24 CORT SCREW SELFT  3.5 X 26 CORT SCREW SELFT  3.5 X 28 CORT SCREW SELFT  3.5 X 30 CORT SCREW SELFT  3.5 X 32 CORT SCREW SELFT  3.5 X 34 CORT SCREW SELFT  3.5 X 36 CORT SCREW SELFT  3.5 X 38 CORT SCREW SELFT  3.5 X 40 CORT SCREW SELFT  3.5 X 45 CORT SCREW SELFT  3.5 X 50 CORT SCREW SELFT  3.5 X 55 CORT SCREW SELFT  3.5 X 60 CORT SCREW SELFT  3.5 X 75 CORT SCREW SELFT
US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY) + District of Columbia; FOREIGN: Bulgaria, China, Germany, Greece, Romania, Singapore, Slovakia, United Kingdom
Digestive enzyme capsules sold under the NOW Foods, Beeyoutiful, Best in Nature, Bluegrass Naturals Vitamin Company, Chicago Nutrition Company, Gluten-Free Remedies, Osa's Garden, and Professional Naturopathics brands and packaged in a plastic bottle containing 60 or 120 capsules.
Digestive enzyme capsules manufactured by NOW Foods may contain the antibiotic chloramphenicol.
Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE,  NH, NJ, NY, OH, OK,  PA,  SC,  TN, TX, UT, VA,  WA, WI, WV.
Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection, USP, 10 mg/mL, Lot 25-090-DK.  Custom Procedural Tray or kit is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Custom procedural trays or kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.
Custom Procedural Trays/Kits which contain 1% Lidocaine HCl injectio were recalled because one confirmed customer report where visible particulate were found in the primary product container in the form of dark red/black particles. The particular matter may dislodge through the tissue and could possibly cause a pneumothorax or hemothorax.
Worldwide Distribution: US (nationwide) Distribution in South Dakota and the countries of Germany, Lebanon, and China.
Access 2 Immunoassay System Analyzer. K922823/A007.     The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Beckman Coulter initiated a recall of the Access 2 Beckman Coulter initiated a recall of the Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access becausethey may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect results.
UniCel DxI 600 Access Immunoassay System Analyzer. K023764.   The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Part Number A30260. Serial Numbers 900781.
Beckman Coulter initiated a recall of the Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access becausethey may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect results.
Nationwide Distribution including AL, CA, DE, IA, IL , IN, KS, KY, MI, MO, NJ, OH, OK, TX, WA, WI,and  WV.
Superstand stand-up wheelchair HPS-2    A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.
Power Superstand Standing Wheel chair, flex shaft (the flexible wand which supports the joystick control module) may fracture if it is bent repeatedly and /or beyond 90 degrees. A newly designed Flexshaft which corrects this problem is available at no charge.
Worldwide distribution: US (nationwide) to states of: LA, CA, NC, IL, PA, and NY; and Internationally to: Seoul, Korea; New Delhi, India; Taipei City, Taiwan; and Madrid, Spain.
External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF  40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL  35244   Usage: dental
The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length.
Blood products, collected from a donor whose physical examination was incomplete, were distributed.
Blood products, collected from a donor who engaged in high risk behavior, were distributed.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood products, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Blood product, with insufficient red cell preservative solution added, was distributed.
Blood Centers of the Pacific - Irwin Center
Blood product, which was not prepared according to specifications, was distributed.
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Nationwide Distribution including GA & TX
Orbit soft Infusion sets, 9 mm soft cannula, P10 (42'') tubing; Single-Use Set Orbit Infusion Sets are sterile, non-pyrogenic, single-use devices intended to be used for subcutaneous delivery of medication , for example insulin, from an external infusion pump.
Perrigo was notified by our supplier, Ypsomed AG, that they are recalling these batches due to being manufactured with a non-conforming female luer-lock connector. The luer-lock connectors are incompatible with standard male luer-lock connectors for use in connection to compatible infusion pumps.  Perrigo became was notified of a quality complaint related to this issue on November 20, 2013 from a distribution customer.
Worldwide Distribution - US Distribution including the states of  AZ, MD, MA, WI, MI, MN, DE, KS, and FL., and the countries of Australia, Germany, Great Britain, Norway and Japan.
Aesculap proSA Adjustment Disc Size Large (L)   The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Nationwide. No foreign.  Includes military/govt/VA consignees.
BACA'S GC Hot 12-13oz Z, Product Item Number 1010-0. Packaged in plastic containers.   All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of  12 units of 13 oz each per case totaling 9.75 lbs.
Products were recalled due to possible Listeria monocytogenes contamination.
Bueno GC NM Autumn Roast Exclusive Hot 5-5# Z, Product Item Number 1015-3. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Bueno GC NM Hatch Valley XXXHot 5-5# Z, Product Item Number 1020-3. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Bueno GC  NM XHot 12-13 oz Z, Product Item Number 1021-1.  Packaged in plastic containers.   All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of  12 units of 13 oz each per case totaling 9.75 lbs.
Bueno GC NM Hot 12-13 oz Z, Product Item Number 1022-1.  Packaged in plastic containers.   All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of  12 units of 13 oz each per case totaling 9.75 lbs.
Bueno GC Organic Mild 12-13 oz Z, Product item Number 1023-1.  Packaged in plastic containers.   All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of  12 units of 13 oz each per case totaling 9.75 lbs.
Bueno GC NM Mild 12-13 oz Z, Product Item Number 1024-1.  Packaged in plastic containers.   All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of  12 units of 13 oz each per case totaling 9.75 lbs.
Bueno GC NM Autumn Roast Hot 12-13 oz Z, Product Item Number 1026-1.  Packaged in plastic containers.   All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of  12 units of 13 oz each per case totaling 9.75 lbs.
Bueno GC NM Hatch Valley Autumn Roast Hot 12-13 oz Z, Product Item Number 1026-2.  Packaged in plastic containers.   All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of  12 units of 13 oz each per case totaling 9.75 lbs.
Bueno GC NM Hatch Valley Blakes SuperHot 5-5# Z, Product Item Number 1028-5. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Bueno GC NM Hot 28oz, Product Item Number 1032-2. Packaged in plastic containers.   All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of  6 units of 28 oz each per case totaling 10.5 lbs.
Bueno GC NM Mild 28oz Z, Product Item Number 1034-2. Packaged in plastic containers.   All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of  6 units of 28 oz each per case totaling 10.5 lbs.
Bueno GC NM Hot 6-56oz Z, Product Item Number 1042-2. Packaged in plastic containers.   All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of  6 units of 56 oz each per case totaling 21 lbs.
Bueno GC NM Mild 6-56oz Z, Product Item Number 1044-2. Packaged in plastic containers.   All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of  6 units of 56 oz each per case totaling 21 lbs.
Bueno GC NM Exclusive XHot 6-56oz Z, Product Item Number 1048-5. Packaged in plastic containers.   All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of  6 units of 56 oz each per case totaling 21 lbs.
GC Medium 5-5# Z, Product Item Number 1055-3. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
GC NO LABEL Hot 5-5# Z, Product Item Number 1056-0. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
GC Exclusive Hot 5-5# Z, Product Item Number 1056-2. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Bueno GC NM Hot 5-5# Z, Product Item Number 1056-3. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Bueno GC NM  Reserve Hot 5-5# Z, Product Item Number 1056-4. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Bueno GC NM  Hatch Valley Hot 5-5# Z, Product Item Number 1056-5. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Bueno GC NM Hot 5-5# Z, Product Item Number 1056-7. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Bueno GC Exclusive Shot 5-5# Z, Product Item Number 1056-8. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
GC NO LABEL Mild 5-5# Z, Product Item Number 1057-0. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Bueno GC NM Mild 5-5# Z, Product Item Number 1057-3. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Bueno GC NM Reserve Mild 5-5# Z, Product Item Number 1057-4. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Bueno GC NM Hatch Valley Mild 5-5# Z, Product Item Number 1057-5. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Bueno GC NM Mild 5-5# Z, Product Item Number 1057-7. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
GC Autumn Roast NO LABEL Hot 5-5# Z, Product Item Number 1062-0. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Bueno GC NM Autumn Roast Hot 5-5# Z, Product Item Number 1062-3. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Bueno GC NM Autumn Roast Hot 5-5# Z, Product Item Number 1062-7. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Bueno GC Strip Mild 2-12.5# Z, Product Item Number 1071-4. Packaged in double-poly bags.
Bueno GC Strip Hot 2-12.5# Z, Product Item Number 1072-4. Packaged in double-poly bags.
Bueno GC Whole Mild 2-12.5# Z, Product Item Number 1073-4. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label.  Total package size of  2 units of 12.5 lbs. each per case, totaling 25 lbs.
Bueno GC NM Hatch Valley Mild 2-12.5# Z, Product Item Number 1077-6. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label.  Total package size of  2 units of 12.5 lbs. each per case, totaling 25 lbs.
Bueno GC NM Hot 2-12.5# Z, Product Item Number 1081-3. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label.  Total package size of  2 units of 12.5 lbs. each per case, totaling 25 lbs.
Bueno GC Autumn Roast Strip Medium 2-12.5# Z, Product Item Number 1090-5. Packaged in double-poly bags and not sealed.
Bueno GC NM Mild 2-12.5# Z, Product Item Number 1093-3. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label.  Total package size of  2 units of 12.5 lbs. each per case, totaling 25 lbs.
Bueno GC 1.5 Hot 5-5# Z, Product Item Number 1096-3. Packaged in sealed poly film pouches.  All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size  5 units of 5 lbs each per case, totaling 25 lbs.
Worldwide Distribution: US (nationwide) including Puerto Rico and the states of: AL, AK, AZ, CA, CO, CT, FL, GA, IL, IA, KY, MD, MA, MI, MN, MS, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, WI, DC, and  Internationally to: Algeria, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Malaysia, Mexico, Pakistan, Portugal, Russia, Singapore, Slovakia, South Korea, Spain, Taiwan, Thailand, and United Kingdom.
Synergy XVI   The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Potential collision risk when using XVI and external beam shaping devices.
Worldwide Distribution - USA (nationwide) including Puerto Rico and  the states of AL, AK, AZ, AR, CA, CT, FL, GA, ID, IL, KY, LA, MD, MA, MI, MN, MO, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SD, TN, TX, VT, VA, WA, WV, WI, WY and DC., and the countries of  Algeria, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and Venezuela
Synergy XVI   XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very frequently. This is the sequence of events when this error occurs - (1) You do an online VolumeView acquisition and registration. (2) You accept the registration and the Table Move Assistant dialog box appears. (3) The Relative Actual column of the Table Move Assistant dialog box incorrectly appears blank. (4) When this occurs, XVI does not read the Absolute Actual position of the treatment table. This causes XVI to calculate the treatment table moves from the zero position of the treatment table (+0.0, + 0.0, + 0.0). (5) In XVI R5.0, if the Relative Set values are less than or equal to + or -2.5cm (for earlier releases of XVI, the value is + or -2cm), you can do remote automatic table movement (RATM) from the function keypad (FKP). (6) When you press the Table ASU (automatic setup) buttons, the treatment table moves to a position that was incorrectly calculated from XVI.
XVI can incorrectly calculate the target position of the treatment table.
All product in these lots were shipped to Canada.
Similac Human Milk Fortifier Powder, .9 g packets. Label reads in part, ''ADDITIONAL IRON MAY BE NECESSARY ADD ONLY TO HUMAN MILK - DO NOT ADD WATER NET WT 0.031 OZ (0.90g)***CONTAINS MILK AND SOY INGREDIENTS***USE BY***ABBOTT LABORATORIES''
Abbott Nutrition (AN) recalled this product from the Canadian market because some of the packets may have an incomplete seal which could allow air to enter the packet causing food oxidation and/or the powder to leak
SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites.   A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
Complaints were received reporting leakage on certain lots of SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites.The SAFSITE Injection Site is intended to provide needle free access on IV and Extension Sets.
Siemens Prisma 2K Hearing Aid   Product Usage:  A behind the ear (BTE) hearing aid developed for pediatric patients.
Siemens became aware of an issue where an infant or child could open the tamper resistant battery compartment of the Siemens Prisma 2K hearing aid under certain unintended use conditions.
Synthes Driving Cap/Threaded   Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired, the nail can then be inserted using light hammer blows.
The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assembled becoming difficult to separate.
Worldwide Distribution: US (nationwide) and Internationally to: Great Britain, France, Spain, Portugal, Sweden, Russia and Guadeloupe.
Bausch & Lomb AKREOS AO Micro Incision Lens    The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.
336 IOLs (283 IOLs in the US, 53 IOLs outside the US)
Lens was manufactured with incorrect raw material.
Kinnikinnick Gluten Free Original Homestyle Waffles Frozen  Contains a logos on the package indicating it is gluten free, dairy free, and nut free.   210 g/7.4oz Qty/pkg - 6.  UPC 62013300198 1.  DPI item # 55844.
DPI Specialty Foods NW is recalling Kinnikinnick Brand gluten free original homestyle waffles because they have the potential to contain the allergen milk, which is not declared on the label.  Package contains a logo which indicates the product is dairy free.
''  Arizona          ''  California             ''  Colorado           ''  Florida           ''  New Jersey           ''  New York           ''  Nevada             ''  Oklahoma            ''  Texas           ''  Utah
STEMALIVE, 90 Capsules.   The product is in a white plastic bottle with white lid, the brand is StemVida International with a white and gold label.    Product labeling reads in part:''STEMVIDA INTERNATIONAL***StemAlive***PROMOTES ADULT STEM CELL FUNCTION AND HEALTH***Dietary Supplement***90 Capsules***Formulated exclusively for STEMVIDA International Corporation 4295 Jurupa St Ste 116, Ontario CA 91741***This exclusively formulated product is only available through ETEMVIDA International independent distributors***www.stemvidainternational.com***''.    The StemAlive product is shipped as a single unit or in boxes of 4 units or 16 units.
Stemvida International Corporation of Ontario California is recalling certain lots of StemAlive 90 Capsules, because it contains undeclared milk.
Kinnikinnick Original Homestyle Waffles Weight: 210 g/7.4oz Qty/Pkg: 6 Cardboard Box  UPC: 62013300198 1
Cal Fresh Produce is recalling Kinnikinnick Foods Original Homestyle Waffles due to undeclared milk.
Dried Tapioca Pearl, Net Wt. 7oz, 50 bags/carton, UPC Code 0893467803068
Product contains unapproved colors, 16185-Amaranth (E123)-Delisted FD&C Red #2, 45170-Rhodamine B-Basic Violet 10, 42000-Malachite Green-Basic Green 4, 4100-Auramine O-Basic Yellow 2, and undeclared colors FD&C Yellow #5 and FD&C Blue #1.
Worldwide Distribution - USA including AL, AZ, AR, CA, CO, FL, GA, IL, IN, IA, KY, LA, MN, MO, NE, NJ, NM, NY, NC, OH, OK, PA, SD, TN, TX, UT, VA, WA, WV, WI and Internationally to:   AUSTRALIA, AUSTRIA BELGIUM BOSNIA AND HERZEGOVINA, BRAZIL, CANADA, CHILE, COLOMBIA, CHINA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FRANCE, FINLAND, GEORGIA, GERMANY, HONG KONG, IRAN, ISRAEL INDIA,M ITALY, JAPAN, JORDAN, KUWAIT, LEBANON, MALAYSIA, MEXICO, MOROCCO, NEW ZEALAND, NORWAY, RUSSIA, REPUBLIC OF KOREA, POLAND, ROMANIA, SAUDI ARABIA, SPAIN, SWEDEN SWITZERLAND, TAIWAN, TUNISIA, THAILAND, TURKEY, UNITED KINGDOM.
GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690.   The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems.
GE Healthcare has recently become aware of a potential safety issue due to scatter overcorrection associated with the List Mode Replay feature of your Discovery 600, 610, 710 and Discovery 690.
Worldwide Distribution: USA (nationwide) including DC and PR; and Internationally to: ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOSNIA-HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CAMBODIA, CAMEROON, CANDA, CARIBBEAN, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DJIBOUTI, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GABON, GEORGIA, GERMANY, GHANA, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNGARIA, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, IVORY COAST, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, MACEDONIA, MALAYSIA, MALTA, MAURITIUS, MEXICO, MOLDOVIA,MOROCCO, NEPAL, NETHERLAND, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SENEGAL, SERBIA MONETENO, SINGAPORE, SLOVAKIA, SLOVENIA SOUTH AFRICA, SPAIN, SRI LANKA, SUDAN, SWEDEN SWITZERLAND, SYRIA, TAIWAN, TAJIKISTAN, TANZANIA, THAILAND, TRINIDAD TOBAGO, TUNISIA, TURKEY, TURKMENISPAN, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM, YEMEN, and ZIMBABWE.
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station.
GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor and Dash Port 2 Docking Station:   DASH:   1. Dash stops communicating on the Unity Network resulting in Loss of Monitoring at the CARESCAPE'' CIC Pro Central Station*.  2. Dash displays distorted ECG waveforms in combination monitoring mode.   3. Dash incorrectly becomes Time Master on the Unity Network.  4. Dash date reverts to 1993.    DASH PORT 2:  Dash Port 2 stops communicating on the Unity Network resulting in Loss of Monitoring at the CARESCAPE'' CIC Pro Central Station*.    *Despite communication loss, the Dash 3000/4000/5000 will continue to provide bedside monitoring including alarms and event storage.
Worldwide Distribution - USA (nationwide) and the countries of  Australia, Austria, Denmark, France, Germany, Netherlands, Poland, Singapore, Sweden, Switzerland and United Kingdom.
Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a secondary display control unit, where the device monitors the vital signs of a patient undergoing an MRI procedure from the MR control room, induction room, or recovery room and then outputs the measured patient data to a hospital information system (HIS).   The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI procedures.
Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expression Information Portal (Model IP5). Upon power up, the IP5 may fail to produce audio.
Worldwide Distribution-USA (nationwide) and the countries of Canada and Switzerland.
Synthes 3.2 mm Guide Wire 400mm.   Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.
Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label.
Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible.
One lot of Matrix Mandible Short Threaded Drill Guides (part No. 03.503.043) has a gray colored band instead of a green colored band as pictured in the Technique Guide.
Medtronic Inc. Cardiac Rhythm Disease Management
Worldwide distribution: US (Nationwide) including Puerto Rico, and Internationally to: Algeria, Argentina, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, Cyprus, El Salvador, France, Georgia, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Jordan, Kuwait, Netherlands, Oman, Paraguay, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Venezuela, and Yemen.
Medtronic Select 3D Arterial Cannulae.  Vented, models 78618  (18 Fr.) and 78620 (20 Fr.).  Non-Vented Cannulae, models 78718 (18 Fr.) and 78720 (20 Fr.).  Sterilized using Ethylene Oxide.  Non-pyrogenic.     The Select 3D Arterial Cannulae both have clear flexible, thin wall wire-wound PVC bodies with angled, beveled tips.  The proximal end of the cannula includes a 3/8'' (0.95 cm) vented or non-vented connector with a peel cap.  The vented connector allows air to be vented from the cannula before connection to the perfusion line.    The Select 3D Arterial Cannula tip has three integrated flutes which help diffuse and disperse blood flow.  The cannula body features a tip orientation line indicating direction of the cannula tip during cannulation.  Overall cannula length is 11.5'' (29.2 cm).      These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.
Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar.
Medtronic Select 3D Arterial Cannulae.  Vented, model 78622  (22 Fr.).  Non-Vented Cannulae, model 78722 (22 Fr.).  Sterilized using Ethylene Oxide.  Non-pyrogenic.     The Cannula consists of a curved, angled or beveled tip with or without flange that is permanently attached to a molded, clear, flexible PVC tapered body or wirebound PVC body.  The cannula body features a tip orientation line to indicate direction of the cannula tip during cannulation.  The proximal end of the cannula includes a connection site or a molded 0.95 cm (3/8 in) barbed connector with or without a molded plastic vent plug or peel cap.  The vent plug or peel cap allows air to be vented from the cannula before connection to the perfusion line.     These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.
Medtronic Select 3D Arterial Cannulae.  Vented, model 78624  (24 Fr.).  Non-Vented Cannulae, model 78724 (24 Fr.).  Sterilized using Ethylene Oxide.  Non-pyrogenic.     The Cannula consists of a curved, angled or beveled tip with or without flange that is permanently attached to a molded, clear, flexible PVC tapered body or wirebound PVC body.  The cannula body features a tip orientation line to indicate direction of the cannula tip during cannulation.  The proximal end of the cannula includes a connection site or a molded 0.95 cm (3/8 in) barbed connector with or without a molded plastic vent plug or peel cap.  The vent plug or peel cap allows air to be vented from the cannula before connection to the perfusion line.      These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.
Medtronic Select CAP Arterial Cannulae.  Vented, models 78818  (18 Fr.), 78820 (20 Fr.), 78822 (22 Fr.).  Non-Vented Cannulae, model 78920 (20 Fr.), 78922 (22 Fr.), 78924 (24 Fr.).  Sterilized using Ethylene Oxide.  Non-pyrogenic.     The Cannula consists of a curved, angled or beveled tip with or without flange that is permanently attached to a molded, clear, flexible PVC tapered body or wirebound PVC body.  The cannula body features a tip orientation line to indicate direction of the cannula tip during cannulation.  The proximal end of the cannula includes a connection site or a molded 0.95 cm (3/8 in) barbed connector with or without a molded plastic vent plug or peel cap.  The vent plug or peel cap allows air to be vented from the cannula before connection to the perfusion line.  The proximal end features a pressure monitoring line with a 3-way stopcock.    These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.
Medtronic Select CAP Arterial Cannulae.  Non-Vented, Carmeda Coated, model CB78722 (22 Fr.).  Sterilized using Ethylene Oxide.  Non-pyrogenic.     The Select 3D Arterial Cannulae has clear flexible, thin wall wire-wound PVC bodies with angled, beveled tips.  The proximal end of the cannula includes a 3/8'' (0.95 cm) vented or non-vented connector with a peel cap.  The vented connector allows air to be vented from the cannula before connection to the perfusion line.    The Select 3D Arterial Cannula tip has three integrated flutes which help diffuse and disperse blood flow.  The cannula body features a tip orientation line indicating direction of the cannula tip during cannulation.  Overall cannula length is 11.5'' (29.2 cm).      These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.
Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae.  Model 3Y90R3, the following model is only approved in Europe C300901B.  Sterilized using Ethylene Oxide.  Non-pyrogenic.     The design and components of this product are specified by the user.      This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures.
Mega Slim Herbal Appetite Management, 30 Capsules Bottle.   Product labeling reads in part:''MEGASLIM Herbal Appetite Management***30 Capsules***YoungYou Weight Loss Center***MegaSim Propriety Blend 590 mg, Garcinia Cambogia Extract, Green Tea, Aloe Ferox, L-Carnitine, Caralluma fimbriata Extract***Distributed by YoungYou International Inc. Earth Creation, USA (877) 496-8649  www.youngyoucorp.com***''.
No Lot Codes. Product sold/distributed September 15, 2013 through January 23, 2014.    UPC code 7 36211 61409.  Expiration date June 2014.
YoungYou International is voluntarily recalling Mega Slim Herbal Appetite Management, 30 capsules, sold from September 15, 2013 through January 23, 2014, because it was found to contain DMAA.
Worldide Distribution - USA (nationwide) amd Internationally to: ARAB EMIRATES, AUSTRIA, AUSTRALIA, BANGLADESH, BELGIUM, BULGARIA, BRAZIL, CHINA, COLUMBIA, COSTA RICA, CZECH REPUBLIC, DOMINIACAN REPUBLIC, EGYPT, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, HONG KONG, HUNGARY, INDONESIA, IRELAND, ISRAEL, INDA, ITALY, JAPAN, KUWAIT, LYBIA, LATVIA, MACEDONIA, MEXICO, MAYLAYSIA, NETHERLANDS, PAKISTAN, PHILLIPINES, POLAND, PORTUGAL, QUWAIT, SAUDIA ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWITZERLAND, TAIWAN, THAILAND, TUNISIA AND VIETNAM.
Integra Cusa Excel Rx Only   CEM'' Nosecone  for CUSA Excel System    Product Usage:  Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
The blue COAG button on the CUSA Excel CEM nosecone could stick in the 'activated' position.
Mid Pac Foods brand sauce for Char Sui; Net 7 FL. oz (207 ml);  Made in Hawaii, Keep in cool place  UPC: 7336620250    Manufactured by Mid Pac Foods, Inc.  Honolulu, HI.
Inspection at firm found that sauce for Char Siu declares Hoisin sauce as an ingredient, but does not declare the sub ingredient of wheat.
Worldwide Distribution - USA (nationwide)  in the states of: CA, AZ, IL, NC, CO and the country of: South Africa.
Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766.   Product Usage:    To be used where limb support and/or elevation is considered necessary.
Catalog Number SLV634, Lot Number 852766.
Implantech initiated the voluntary recall of Gelzone Shoulder Sleever, SLV-634, Lot Number 852766 because it may not satisfy customer requirements for the robustness of the Velcro closure.
IQF Stuffed Brined Jalapeno Peppers w/Gorgonzola Allergen: Milk, Wheat. Prod.Code: 4013    24/30 lb bags - 720 lb totes    Keep Frozen  Bin#    Comarco Products 501 Jackson Street, Camden, NJ 08104
Gorgonzola stuffed jalapeno peppers tested positive for Listeria monocytogenes.
US Distribution including the states of FL, MA, WY. OH, MI and KS.
MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length:  Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic:  BioCardia Inc.  San Carlos, CA 94070    Intended to provide a pathway through which medical instruments such as balloon dilation catheters, guidewires and other therapeutic devices may be introduced into the peripheral vasculature.
Catalog number MAP690; Lot numbers 01162 and 01186.
Tyvek packaging may be worn, causing loss of package integrity.
Worldwide Distribution - USA including CA, KY, NJ, MA, and UT and Internationally to Belgium, Austria, and Germany.
CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-124   WITH THE CARTOUNIVU MODULE, FLUOROSCOPIC CAPTURES (IMAGES AND CINE CLIPS) CAN BE IMPORTED TO AND DISPLAYED IN THE CART0 3 SYSTEM. THESE IMAGES ARE NOT FOR DIAGNOSTIC PURPOSES. WHEN FLUOROSCOPIC CAPTURES ARE INTEGRATED INTO THE CART0 3 SYSTEM MAP VIEWERS (MAP VIEWER AND ADDITIONAL VIEW), CART0 3 MAPS, MRl OR CT IMAGES, AND CATHETER VISUALIZATION ARE SUPERIMPOSED ON THE FLUOROSCOPIC CAPTURE.
Biosense Webster has initiated a recall of the  CartoUnivu Module within the Carto 3 System (V3.2.2 and V3.2.3) when used with Siemens Axiom Artis VB Fluoroscopy systems in particular procedural configurations only.  If the table rotation is not returned to zero point, there is a misalignment between the Carto 3 System map display and the fluoroscopic capture.