Community Blood Center of Greater Kansas City
Blood product, which did not meet the acceptable product specifications, was distributed.
Blood products, collected from a donor with a history of living in an HIV-O risk area, were distributed.
Blood and Blood Products for Reprocessing
Blood products, which were labeled as leukoreduced, but did not have leukoreduction testing completed were distributed.
Blood products, collected using equipment that was not validated, were distributed.
Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
Victory 9 with Power Seat (SC609PS)   Motorized wheelchair with elevating seat.
The main harness connector was manufactured without the required back shield sealing protection. As a result, there is the potential for water to seep through the nonconforming harness.
Blood products, collected from a donor whose arm inspection was not documented, were distributed.
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Surgical Tissue Network, Inc. dba TissueNet
Products were distributed to NJ, TX, NH, NY, PR; and to Turkey, Korea, and Chile.
UltraC1 or C2, Cervical is labeled in part:  ''***Expiration***Freeze Dried: Store at 10 C - 37 C***Sterilization Method: T106 Terminal Sterilization System***Donated Human Tissue Allograft / Sterile {SAL 10-6, Non-Irradiated***Single Patient Use Only***''.     Small label:  ''***ID:***UltraC1, Cervical***FD57506, 6mm  Small label:  ''***ID:***UltraC1, Cervical***FD57507, 7mm  Small label:  ''***ID:***UltraC1, Cervical***FD57508, 8mm  Small label:  ''***ID:***UltraC2, Cervical***FD57607, 7mm
Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
Cancellous Crushed is labeled in part:  ''***Tissue ID:***Description:  Cancellous Crushed***Size 15cc-4mm-10mm***Product Code FD55315R***Expiration***Freeze Dried: Store at 10 C - 37 C***Sterilization Method: T106 Terminal Sterilization System***Donated Human Tissue Allograft / Sterile {SAL 10-6, Non-Irradiated***Single Patient Use Only***''.     Small label:  ''***ID:***Cancellous Crushed***FD55315R EXP:***TissueNet 800-465-8800***''
Cancellous Crushed is labeled in part:  ''***Tissue ID:***Description:  Cancellous Crushed***Size 30cc-4mm-10mm***Product Code FD55330R***Expiration***Freeze Dried: Store at 10 C - 37 C***Sterilization Method: T106 Terminal Sterilization System***Donated Human Tissue Allograft / Sterile {SAL 10-6, Non-Irradiated***Single Patient Use Only***''.     Small label:  ''***ID:***Cancellous Crushed***FD55330R EXP:***TissueNet 800-465-8800***''
Ultrafill DBM Human is labeled in part:  ''***Tissue ID:***Description:  Ultrafill DBM Human***Size 10cc***Product Code HM53010***Expiration***Freeze Dried: Store at 10 C - 37 C***Sterilization Method: T10^6 (r)minal Sterilization System***Donated Human Tissue Allograft / Sterile {SAL 10-6, Non-Irradiated***Single Patient Use Only***''.     Small label:  ''***ID:***Ultrafill DBM Human***HM53010 EXP:***TissueNet 800-465-8800***''
Ultrafill DBM Human is labeled in part:  ''***Tissue ID:***Description:  Ultrafill DBM Human***Size 5cc***Product Code HM53005***Expiration***Freeze Dried: Store at 10 C - 37 C***Sterilization Method: T10^6 (r)minal Sterilization System***Donated Human Tissue Allograft / Sterile {SAL 10-6, Non-Irradiated***Single Patient Use Only***''.     Small label:  ''***ID:***Ultrafill DBM Human***HM53005 EXP:***TissueNet 800-465-8800***''
Mineralized Bone is labeled in part:  ''***Processed by: TissueNet***7022 TPC Dr Ste 400***Orlando, FL 32822***Sterilized By: T106^(r) {SAL 10-6}***Tissue ID:***Description:  Mineralized Bone***Size 5cc***Product Code MB50050***Expiration***Freeze Dried: Store at 10 C - 37 C***Donated Human Tissue Allograft***Single Patient Use Only***''.     Full Product Description:  Mineralized Bone .125-.85mm 5cc
Fashioned UltraBTB is labeled in part:  ''***Sterile {SAL 10-6} T106 Terminal Sterilization System***Tissue ID:***Description Fashioned UltraBTB***Size***Product Code FF99050***EXPIRATION:***Store at -40 c or Cooler***Donated Human Tissue Allograft***Single Patient Use Only***ID:***Fashioned UltraBTB***FF99050 EXP:***TissueNet 800-465-8800***''     Full Product Description:  Fashioned UltraBTB 10x10mm
Fashioned UltraAchilles is labeled in part:  ''***Sterile {SAL 10-6} T106 Terminal Sterilization System***Tissue ID:***Description Fashioned UltraAchilles***Size***Product Code FF94355***EXPIRATION:***Store at -40 c or Cooler***Donated Human Tissue Allograft***Single Patient Use Only***ID:***Fashioned UltraAchilles***FF94355 EXP:***TissueNet 800-465-8800***''     Full Product Description:  Fashioned Achilles 9mm
UltraTibialis (Anterior) is labeled in part:  ''***Sterile {SAL 10-6} T106 Terminal Sterilization System***Tissue ID:***Description UltraTibialis (Anterior)***Size***Product Code FF84230***EXPIRATION:***Store at -40 c or Cooler***Donated Human Tissue Allograft***Single Patient Use Only***ID:***UltraTibialis (Anterior) ***FF84230 EXP:***TissueNet 800-465-8800***''     Full Product Description:  Ultra Tibialis Anterior
UltraP (Peroneus Longus) is labeled in part:  ''***Sterile {SAL 10-6} T106 Terminal Sterilization System***Tissue ID:***Description UltraP (Peroneus Longus)***Size***Product Code FF93500***EXPIRATION:***Store at -40 c or Cooler***Donated Human Tissue Allograft***Single Patient Use Only***ID:***UltraP (Peroneus Longus)***FF93500 EXP:***TissueNet 800-465-8800***''     Full Product Description:  Ultra Peroneus Longus
Ultra Tibialis (Posterior) is labeled in part:  ''***Sterile {SAL 10-6} T106 Terminal Sterilization System***Tissue ID:***Description Ultra Tibialis (Posterior)***Size***Product Code FF84231***EXPIRATION:***Store at -40 c or Cooler***Donated Human Tissue Allograft***Single Patient Use Only***ID:***Ultra Tibialis (Posterior)***FF84231 EXP:***TissueNet 800-465-8800***''     Full Product Description:  Ultra Tibialis Posterior
Ultra Semi-T (Semitendinosus) is labeled in part:  ''***Sterile {SAL 10-6} T106 Terminal Sterilization System***Tissue ID:***Description Ultra Semi-T (Semitendinosus)***Size***Product Code FF83100***EXPIRATION:***Store at -40 c or Cooler***Donated Human Tissue Allograft***Single Patient Use Only***ID:***Ultra Semi-T (Semitendinosus)***FF83100 EXP:***TissueNet 800-465-8800***''
Fascia Lata, Large is labeled in part:  ''***Tissue ID:***Description:  Fascia Lata, Large***Size:***Product dimension***Product Code FD73520***EXPIRATION***Freeze Dried: Store at 10 c - 37 c***Sterilization Method: T106 Terminal Sterilization system***Donated Human Tissue Allograft / Sterile {SAL 10-6, Non-Irradiated***Single Patient Use Only***ID:***Fascia Lata, Large***FD73520 EXP:***TissueNet 800-465-8800***''
Affected products were distributed to Israel, South Korea, United Kingdom , Turkey and domestically to TX, FL, MI, IN, NJ, IL, MO AZ, OK, OK and WI.
Cancellous Chips.  Product is labeled in part:  ''***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method:  supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***''   .25-.5mm 15cc Cancellous Chips, Product Code 0306Al
Tissue ID/Donor ID# Al1000082005 and Al1000082006
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Cancellous Chips.  Product is labeled in part:  ''***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method:  Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***''   .5-1mm 15cc, 30cc, and 1cc Cancellous Chips:  Product Code 0308Al, .5-1mm 15cc Cancellous Chips  Product Code 0309AI, .5-1mm 30cc Cancellous Chips  Product Code 0326AI, .5-1mm 1cc Cancellous Chips
Cancellous Chips.  Product is labeled in part:  ''***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method:  Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***''   1-4mm 15cc, 30cc, and 60cc Cancellous Chips  Product Code 0310Al, 1-4mm 15cc Cancellous Chips  Product Code 0311AI, 1-4mm 30cc Cancellous Chips  Product Code 0313AI, 1-4mm 60cc Cancellous Chips
Cancellous Chips.  Product is labeled in part:  ''***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method:  Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***''   4-10mm 15cc, 30cc, and 60cc Cancellous Chips:       Product Code 0317AI, 4-10mm 15cc Cancellous Chips    Product Code 0318Al, 4-10mm 30cc Cancellous Chips  Product Code 0320Al. 4-10mm 60cc Cancellous Chips
Achilles with Bone Block.   ''***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #***Store At: Room Temperature Freeze Dried***Sterilization Method:  supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***''   Product Code 0201Al
Patella Hemi.   ''***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #***Store At: Room Temperature Freeze Dried***Sterilization Method:  Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***''   Product Code 1901Al
Patella Hemi Pre-Sized.   ''***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #***Store At: Room Temperature Freeze Dried***Sterilization Method:  Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***''   Product Code 1903Al
Tibialis Anterior  ''***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #***Store At: Room Temperature Freeze Dried***Sterilization Method:  Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***''   Product Code 2701Al
Tibialis Posterior  ''***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #***Store At: Room Temperature Freeze Dried***Sterilization Method:  Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***''   Product Code 2702Al Donor#/Tissue ID# A100011-0012 and A100011-0013.
Peroneous Longus ''***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #***Store At: Room Temperature Freeze Dried***Sterilization Method:  Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***''   Product Code 2101Al
Integra LifeSciences Corp. d.b.a. Integra Pain Management
Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs and other medical materials that will support the administration of spinal anesthesia for use by a surgeon, nurse or other licensed medical professional.  Model number is 3403644.   The intended use of this tray is to provide the surgeon, nurse or other licensed medical professional, a kit of sterile instruments, drugs and other medical materials that will support the administration of anesthesia, be it local, spinal or general administration.
Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components.
Worldwide Distribution-USA (nationwide) including the states of  AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and Puerto Rico and the countries of Australia, Germany, New Zealand.
TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model Number(s): TDXSI, TDXSI-2, TDXSI-2-S, TDXSI-CG, TDXSI-HD, TDXSI-HD-S, TDXSIV, TDXSIV-2, TDXSIV-2-S, TDXSIV-HD, TDXSIV-HD-S, TDXSP, TDXSPBASE, TDXSP-CG, TDXSPEURO, TDXSP-MCG, TDXSP-MCG-GT, TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-MCG, FDX, FDX-CG, FDXEURO-14, FDX-MCG. Mrf. By: Invacare Corporation, 1200 Taylor Street, Elyria, OH 44035.   Intended to provide mobility to a person restricted to a sitting position.
TDXSI, TDXSI-2, TDXSI-2-S, TDXSI-CG, TDXSI-HD, TDXSI-HD-S, TDXSIV, TDXSIV-2, TDXSIV-2-S, TDXSIV-HD, TDXSIV-HD-S, TDXSP, TDXSPBASE, TDXSP-CG, TDXSPEURO, TDXSP-MCG, TDXSP-MCG-GT, TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-MCG, FDX, FDX-CG, FDXEURO-14,  and FDX-MCG.
665 affected power wheel chairs and 15 post-fuse assembly service parts have been identified.
Invacare Corporation decided to recall the product because of a potential risk of fire and serious injury. The post fuse assemblies could potentially have a  short between the positive ring terminal and the terminal battery bracket which would create an alternate current path around the fuse.
Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and  WV.
ULTIMA*LX STM,POL 10/12TAP/SZ1   Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped.    Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots
DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle.  This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
ULTIMA*LX STM,POL 10/12TAP/SZ2   Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped.    Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
ULTIMA*LX STM,POL 10/12TAP/SZ3   Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped.      Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
ULTIMA*LX STM,POL 10/12TAP/SZ4   Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped.        Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
ULTIMA*LX STM,POL 10/12TAP/SZ5   Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped.    Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
ULTIMA*LX STM,POL 10/12TAP/1M   Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped.    Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
ULTIMA*LX STM,POL 10/12TAP/2M   Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped.    Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
ULTIMA*LX STM,POL 10/12TAP/3M   Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped.    Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Product code: 853158 and Lot numbers: 550633, 642337, XDG35, XDG36, XED10, XFE24, XHL14, XHL15, YAX31, and YGN25.
ULTIMA*LX STM,POL 10/12TAP/4M   Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped.    Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
LUSTER HIP SZ 1   Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors.    Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
(85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots
LUSTER HIP SZ 2   Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors.    Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
LUSTER HIP SZ 3 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors.    Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
LUSTER HIP SZ 4   Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors.    Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Eighty-five (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots
LUSTER HIP SZ 5   Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors.    Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Product code:152180005 and Lot numbers: AH7DVA000 and VJ3B21003.
LUSTER HIP SZ 6   Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors.    Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
LUSTER HIP SZ 7   Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors.    Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
LUSTER HIP SZ 8   Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors.    Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Product code:152180008 and Lot numbers: A5BDJ1000, A73C51000, AH6D21000, X4GBW1000, and Z2YCR1000.
LUSTER HIP SZ 9   Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors.    Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
LUSTER HIP SZ 10   Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors.    Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Product code:152180010 and Lot numbers: A4VCY1000 and T76A61007.
85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots
Metoprolol Tartrate Tablets USP 50 mg, 1000 count bottle, Rx only, Manufactured in india By: Emcure Pharmaceuticals LTD. Hinjwadi, Pune, India, Manufactured for TEVA Phamaceuticals USA, Sellersville, PA 18960, NDC 0093-0733-10
Tablet Thickness: Potential for some tablets not conforming to weight specifications (under and over weight)
Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.
Imodium Multi-Symptom Relief Caplets, Loperamide HCl 2 mg/Simethicone 125 mg, 18 count blister pack cartons, McNeil Consumer Healthcare, Div of McNeil-PPC Inc., Fort Washington, PA
Defective Container; damaged blister units
DePuy Mitek, Inc., a Johnson & Johnson Co.
Worldwide Distribution-USA (nationwide) and the countries of  Canada, Austria, China, Croatia, Czech Republic, France, Germany, Greece, Hungary, Italy, Lebanon, Netherlands, New Zealand, Poland, Russian Federation, Singapore, South Africa, Spain, Switzerland, Turkey, UAE, and UK.
Depuy Spine Side Fire Needles 13G X 6IN,  part of the Confidence Spinal Cement System Product Code 283904613.    The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle.
Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement System Product Code: 283904411.    The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle.
Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle, part of the Confidence Spinal Cement System  Product Code 283904611.    The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle.
Additional  Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904413.    The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle.
US distribution only: Illinois, Wisconsin and Minnesota.
Dannon Fruit on the Bottom, Raspberry flavor.  6oz form fill seal cup yogurt with predominantly blue labelling.
1,350 cases for all products in Recall Event
Routine testing by the firm showed the presence of Coliforms in absence of E. coli.
Dannon Fruit on the Bottom, Mixed Berry flavor.  6oz form fill seal cup yogurt with predominantly blue labelling.
Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution, 7%), 7.5 oz bottle, Distributed by Ranbaxy, Jacksonville, FL 32257, NDC 10631-106-08
Subpotent (single Ingredient Drug): out of specification result for coal tar content assay.
Worldwide distribution: USA (nationwide) including Puerto Rico and internationally to: Canada, Egypt, France, Germany, Great Britain, Italy, Kuwait, Mexico, Portugal, Saudi Arabia, Spain, Taiwan and United Arab Emirates.
AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico   Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.
The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system.  This leak could lead to a decrease in the tidal volume delivered to the ventilated patient.
AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico   Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.
AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; an Rx device for single patient use; 30 connectors per box; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico   Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.
product codes 5925-504 and 6603-504; includes all lot numbers of the affected product codes manufactured prior to February 3, 2012, lot #0000414257 and any lot numbers beginning with the letter Y.
Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, GA, IL, IA, KY, ME, MA, MI, MN, MS, NJ, NM, NY, PA, PR, SC, TX, VT, and VA. and the countries of SWITZERLAND, ITALY, ISRAEL, IRELAND, COLOMBIA, SWEDEN, INDIA, SINGAPORE, SERBIA, SAUDI ARABIA, CANADA, TAIWAN, SOUTH AFRICA, FRANCE, BRAZIL, MALTA, MACEDONIA, MALAYSIA, FINLAND, ECUADOR, VENEZUELA, REPUBLIC OF KOREA, NETHERLANDS, PERU, UNITED ARAB EMERITES, TURKEY, POLAND, and LEBANON.
Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303,  Gram Stain Control Slides, SLO3-10, ATCC Licensed Derivative, MediMart Europe, 11 rue Emile, Zola B.P. 2332, 38933 Grenoble Cedex 2 France.   They are microscope slide preparations contains specific organisms populations of known and predictable characteristics. These slide support formal quality assurance programs by serving as quality control challenges to demonstrate and document satisfactory performance of staining regents and methods used in staining procedures and to document personnel's ability to perform the procedure and to properly interpret the microscopic test results.
Microbiologics is recalling a number of lots of KWIK-QC Gram Stain Slides.  This product gram negative control organism (E.coli) is not properly fixated on the slide, which may cause the user to unintentionally contaminate the patient area of the slide by flooding the control well with stain.  This contamination could potentially lead to misdiagnosis and improper treatment of a patient.
Pear juice concentrate 70 Brix in 55 gallon steel drums with plastic liner that are filled to 52 gallons.  Labeled in part: ''CLAREX PEAR JUICE CONCENTRATE ''cRc-KOSHER''***52 GALLONS'' and ''TREE TOP***PEAR CONCENTRATE TYPE III***RESOURCE #: 4200815003***Selah, Wa. 98942***MADE IN USA***''.
The product contains in excess of 23 ppb inorganic arsenic which exceeds the FDA published level of concern for a chronic exposure.
Global distribution including USA (nationally), Albania, Bahrain, Bulgaria, Canada, Costa Rica, Georgia, India, Malaysia, Nepal, Paraguay, Syria, Taiwan.
Cinnamon Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack.  Packaging is red, white, and black with black, red and white print writing.  The product is advertised for use in fighting against tooth decay. Part number 8419.
Lot numbers: 112933, B5N16, B5PHZ, B5PZN, B5R5Y, B5TRB, B5VY1, B5WQQ, B5Z3J, B65QW, B68MW, B6CG1, B6GTW, B6HPK, B6K7Y, B6NKD, B6T39, B6XCN.
Ultradent is recalling 36 lots of cinnamon flavored Xylishield gum sold in cartons containing 60 individual pieces as well as within the Xylishield dental care kit due to the omission of the major allergen Soy as a sub-ingredient in the ingredients statement.
Xylishield Dental Care Kit containing 60 pieces of Cinnamon Xylishield gum.  The product is packaged in blue and white packaging with black and white print writing.  The product is advertised as a defense against cavities. Part number 8405.
Lot numbers: 114033, B5P67, B5QT8, B5TLF, B5TX2, B5V43, B5W5F, B5XR5, B5Z1X, B66K3, B687V, B6CS2, B6NMP, B6SHW, B6VS9, B6XCG, B6Y9D, B71Q9.
Spearmint Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack.  Packaging is aqua, blue and white with black, aqua and white print writing.  The product is advertised for use in fighting against tooth decay. Part number 8418.
Ultradent is recalling 36 lots of cinnamon flavored Xylishield gum sold in cartons containing 60 individual pieces as well as within the Xylishield dental care kit due to the omission of the major allergen Soy as a sub-ingredient in the ingredients statement.  They are also recalling a single lot of spearmint flavored gum as it was accidentally manufactured with cinnamon flavored product.
Blood Products, collected from  a donor, whose suitability to donate was not adequately determined, were distributed.
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 whose suitability to donate was not adequately determined, were distributed.
Product was distributed to three consignees in CA, OR and UT.
Wheat Germ, brand name PFM, package in bulk tote, approximately 1650 lbs. per tote.  Product SKU is 1344.
Wheat germ product is contaminated with metal fragments, approximately 0.5mm in diameter and range 3-15mm in length.
Worldwide distribution: USA (nationwide) and countries of: Australia, France and Germany.
PathFinder NXT Pivoting Percutaneous Rod Holder   This device is an instrument used during orthopedic surgery. The intended use of the pivoting percutaneous rod holder is to attach to the rod to facilitate rod insertion, positioning, and orientation through the extender sleeves, under the fascia. The rod is secured to the holder by tightening a captive set screw against the rod end in the tip of the holder using the set screw driver. After positioning the rod and securing at least one pedicle screw closure top against the implanted rod, the holder is removed from the rod end by loosening the captive set screw with the set screw driver.
Complaints have been reported where, during surgery, the surgeon was unable to loosen or remove the inserted rod from the rod holder instrument. The complaint investigation showed  the hex mating feature of the set screw was broken and material missing. There were no  reports of fragments of the set screw being left in the patient or that there was any patient or  user injury, but these events were filed as MDR reports since the location of the fi'agments  from the broken set screw were unknown.
Nationwide distribution, including the states of CA, CO, IL, LA, NV, OH, and TX .
S4 Cervical (S4C) Revision Instruments (FW099R and FW101R).  The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery.
All distributed lot numbers and serial numbers
Aesculap Implant Systems, LLC has initiated a voluntary removal of the S4 Cervical (S4C) Occiput Revision Instrument that is part of the S4C Occipital Instrument Set.  The instruments may not thread into the screw properly during a revision surgery due to tolerance issues between the two instruments.
Worldwide Distribution-USA (nationwide) and the countries of  Argentina, Chile, Denmark , Estonia, Finland, France, Germany ,Hong Kong, Ireland, Italy, Malaysia, Netherlands, Poland, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Taiwan, United Kingdom, and Utd. Arab. Emir.
Philips Xcelera Connect, Software  R2.1 L 1 SP2, an interface engine for data exchange.   Philips Xcelera Connect R2.x is a generic interface and data mapping engine between a Hospital Information System (HIS), Imaging Modalities, Xcelera PACS and Xcelera Cath Lab Manager (CLM). This interface engine simplifies the connection by serving as a central point for data exchange. The data consists only of demographic patient information, schedules, textual information and text reports.
Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Worldwide Distribution - USA including CA, KY and Europe.
AirLife MiniSpacer MDI Dispenser Adapter. Dual-Spray MiniSpacer Metered Dose Inhaler (MDI) Dispenser/Adapter with 15 mm connections.    The 15 mm Dual Spray MiniSpacer is a Metered Dose Inhaler (MDI) Dispenser. It is a non-sterile, single-use item, intended to dispense aerosolized medication into a breathing circuit or ancillary circuits. MINISPACER adapters are indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. The 15 mm device is installed and operated by licensed healthcare practitioners in clinical settings. The MiniSpacer is not a metering valve, and does not measure the amount of medication dispensed. The device may also be used in conjunction with a resuscitator bag or in-line with cool or heated humidification, oxygen enriched T-pieces (blow-by) systems connected to tracheal/endotracheal tube. Environments of use include short and long term critical care settings. The 15 mm Dual Spray MiniSpacers design provides standard dimension connectors (15 mm outer diameter x 15 mm inner diameter) for connection to the ventilator circuit. The device design incorporates a dual spray nozzle that allows a path for the medication to travel through the stem and directs it through the dual orifices into the airstream. Principles of Operation A healthcare practitioner installs the 15 mm MiniSpacer MDI adapter in the breathing circuit, according to facility procedures or as ordered by a physician or other licensed health care practitioner. To dispense the prescribed medication, the healthcare practitioner inserts the MDI canister stem into the devices actuator port and manually depresses the MDI canister. The MDI canisters metering valve releases the combination of medication and propellant through the valve stem and out of the devices dual spray nozzle. The plume is simultaneously ejected through upstream and downstream spray orifices along the longitudinal axis of the device. The practitioner administers the medication as pr
PRODUCT CODES    Affected Lot Number(s) (US):   120320, 120410        Affected Lot Number (EU only):   120405     Expiration Date:         Not Applicable        Serial Number:         Not Applicable     UPC Code (individual device):   (01) 00885403167839                       UPC Code (case):   (01) 50885403167834      Brand Name:   AirLife MiniSpacer MDI Dispenser Adapter   Description:   15 mm O.D. / I.D. connections  Catalogue Number:         002092      US Product Code:      CAF  FDA 510(k) Number:   K955805
Internal data identified a molding defect in the 15 mm O.D. / I.D. MiniSpacer meter dose inhaler (MDI) adapter that results in an incomplete fill of the aerosol dispensing pathway.
Northern Catch Harvest of the Sea Fancy Whole Oysters and SeaNet Fancy Whole Oysters; Net Wt. 8 oz (227g) cans, 12 cans per carton; Distributed by Aldi Inc., Batavia, IL 60510-1477; Product of Korea; UPC 0 41498 11984 3
All lots of both brand names sold between February 20, 2009 and May 29, 2012
The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
California, Florida, Indiana, Maryland, Ohio, Tennessee and Texas
Turkey Dripping Type Marinade X1, 50 lb. bags, Manufactured by Newly Weds Foods, Chicago, IL 60639, product G00988
product G00988, lot numbers YE303312 and MT618006
The products were manufactured using a roast meat flavor yeast extract recalled by DSM Nutritional Products, Llc. because it is contaminated with Salmonella.
Firewood Grill Seasoning X2, 25 lb. bags, Manufactured by Newly Weds Foods, Chicago, IL 60639, product G51189
MUFFIN CHOCOCHIPS IMPORTED BY ELCAMPEON LEAMINGTON 519-324-2616 4oz
UPC: 9564000029; and item #003   All products distributed on 5/15/2012.
50 products (Canadian distribution only)
The firm recalled 26 products for undeclared allergens. this product was recalled due to undeclared soy (soy four and soybean oil) and milk (nonfat milk).
MUFFIN PLAIN (MEXICAN SWEET BREAD) IMPORTED BY ELCAMPEON LEAMINGTON 519-324-2616 4oz, UPC: 9564000029; and item #001
80 products (Canadian distribution only)
The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared soy (soy flour and soybean oil).
Muffins with Pecans: 1) MUFFIN W/PECANS (MEXICAN BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4oz; UPC 9564000029, item #002; 2) MUFFIN W/PECANS MEXICAN SWEET BREAD IMPORTED BY MAX PRODUCTS LEAMINTON 519-325-1176 MEXICANTOWN BAKERY DETROIT MI 48210 4.0oz, UPC 9564000029; 3) MUFFINS W/PECANS (MEXICAN SWEET BREAD) IMPORTED BY FIESTA WHOLESALE 226-440-3033 MY LITTLE MEXICO 4.0oz
1) All products distributed on 5/15/2012; 2) all products distributed on 5/11/12; 3) all products distributed on 5/9/12 and 5/16/12
1) 50 products; 2) 200 3) 100 (Canadian distributed only)
The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared soy (soy bean oil and soy flour).
POLVORONES FRESA Y PINA (MEXICAN SWEET BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4/ 4oz
UPC: 9564000016   All products distributed on 5/15/2012.
40 products (Canadian distribution only)
The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared yellow #5, yellow #6 and red #40.
CONCHAS: 1) CONCHAS (MEXICAN BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4/ 4oz, UPC: 0895640000; and item #002; 2) CONCHAS (MEXICAN BREAD) IMPORTED BY FIESTA WHOLESALE 226-440-3033 MY LITTLE MEXICO 4/4.0oz;, UPC 0895640000; 3) CONCHAS (MEXICAN BREAD) IMPORTED BY FIESTA WHOLESALE MISSISSAUGA ON. 416-833-5959 416-509-8349 4/4.0OZ, UPC 0895640000
1) All products distributed on 5/15/2012. 2) All products distributed on 5/9/2012 and 5/16/12  3) All products distributed 5/9-16/2012
1) 50 products; 2) 40; 3) 96(Canadian distribution only)
The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared yellow #6.
CUERNOS: 1) CUERNOS/CROISSANT (MEXICAN SWEET BREAD/Pain sucre) IMPORTED BY MAX PRODUCTS LEAMINGTON 519-325-1176, 4 oz., UPC 9564000035; 2) CUERNOS PLAIN (MEXICAN SWEET BREAD/PAIN SUCRE) IMPORTED BY FIESTA WHOLESALE MISSISSAUGA ON. 416-833-5959 416-509-8349 4.0OZ, UPC: 9564000035
1) All products distributed on 5/11/2012. 2) All products disbributed on 5/9/12 and 5/16/12.
1) 200 products (Canada distributed only); 2) 12
TACOS DE MANZANA (MEXICAN SWEET BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 3.4oz
UPC: 9564000010; and item #002   All products distributed 5/15/2012.
The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared SULFITES.
MAGDALENAS (MEXICAN SWEET BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4.0oz
UPC: 9564000019; and item #002   All products distributed on 5/15/2012.
The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared YELLOW #6.
TORTUGAS (MEXICAN SWEET BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4.0oz
UPC: 9564000053; and item #002   All products distributed on 5/15/2012.
The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared milk (liquid milk added), FD&C yellow #6, and wheat (flour).
MUFFINS CHOCOCHIPS (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 4.0oz 24-MAY-12
UPC: 9564000029   All products distributed on 5/10/12 and 5/17/2012.
The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared milk (nonfat milk), Soy (soybean oil and soy flour), FD&C yellow #6, and wheat (flour).
MUFFINS PLAIN (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 4.0oz 21-MAY-12
UPC: 9564000029; and item #002   All products distributed on 5/10/12 and 5/17/2012.
The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared milk (nonfat milk), soy (soybean oil and soy flour), and wheat (flour).
TORTUGAS (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 4.0oz
UPC: 9564000053; and item #002   All products distributed on 5/10/12 and 5/17/2012.
1) EMPANADAS DE PINA (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 3.4oz 21-MAY-12, UPC: 9564000009 2) EMPANADAS DE PINA (MEXICAN SWEET BREAD/pain sucre) IMPORTED BY FIESTA WHOLESALE 226-440-3033 MY LITTLE MEXICO 3.4oz
1) All products distributed on  5/10/12 and 5/17/2012. 2) All products distributed on 5/9/12 and 5/16/12.
1) 10 products; 2) 100 products (Canada distribution only)
POLVORONES CON FRESA (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 3.4oz 21-MAY-12
UPC: 9564000009   All products distributed on 5/10/12 and 5/17/2012.
The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared YELLOW #6 AND RED #40.
EMPANADAS DE FRESA (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 3.4oz 21-MAY-12
UPC: 9564000009   All products distributed on 5/10/2012 and 5/17/2012.
The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared RED#40.
CONCHAS (MEXICAN BREAD) IMPORTED BY MAX PRODUCTS LEAMINTON 519-325-1176 4/4.0oz
UPC: 0895640000   All products distributed on 5/11/2012.
The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared yellow #5 and yellow #6.
EMPANADAS DE PINA (MEXICAN SWEET BREAD) IMPORTED BY MAX PRODUCTS LEAMINTON 519-325-1176 MANUFACTURED BY MEXICANTOWN WHOLESALE DETROIT MI 48210 3.4oz
UPC: 9564000009   All products distributed on 5/11/2012.
The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared yellow #6 and yellow #5.
MUFFINS PECAN (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY 21-MAY-12 4.0oz
UPC: 9564000029    All products distributed 5/10-17/2012.
126 products  (Canada distribution only)
The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared wheat (flour), milk, and soy (soybean oil and soy flour).
Hannaford brand Mini Frosted Cookies, 10 oz  UPC # 4126872374
Product sold in retail bakery prior to 6/15/12
Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0590-10
Lot number and expiration dates   Eloxatin (OXALIplatin injection) 50mg vial AE41 02/ 2012   Eloxatin (OXALIplatin injection) 50mg vial CA02B 02/ 2012   Eloxatin (OXALIplatin injection) 50mg vial AE27 02/ 2012   Eloxatin (OXALIplatin injection) 50mg vial BL18B 06/ 2012   Eloxatin (OXALIplatin injection) 50mg vial CB13B 06/ 2012   Eloxatin (OXALIplatin injection) 50mg vial CD65B 01/ 2014   Eloxatin (OXALIplatin injection) 50mg vial CE39B 01/ 2014
CGMP Deviations:  Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.
Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg,  Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0591-20
Lot number and expiration dates   Eloxatin (OXALIplatin injection) 100mg vial AD21 02/ 2012   Eloxatin (OXALIplatin injection) 100mg vial AD22 02/ 2012  Eloxatin (OXALIplatin injection) 100mg vial AE24 02/ 2012   Eloxatin (OXALIplatin injection) 100mg vial AE25 02/ 2012   Eloxatin (OXALIplatin injection) 100mg vial AF55 02/ 2012   Eloxatin (OXALIplatin injection) 100mg vial AE26 03/ 2012   Eloxatin (OXALIplatin injection) 100mg vial AF03 03/ 2012   Eloxatin (OXALIplatin injection) 100mg vial AF04 03/ 2012   Eloxatin (OXALIplatin injection) 100mg vial AF21 03/ 2012   Eloxatin (OXALIplatin injection) 100mg vial BL19B 03/ 2012   Eloxatin (OXALIplatin injection) 100mg vial CB11B 04/ 2012   Eloxatin (OXALIplatin injection) 100mg vial CB102B 04/ 2012   Eloxatin (OXALIplatin injection) 100mg vial CB12B 04/ 2012   Eloxatin (OXALIplatin injection) 100mg vial CA01B 04/ 2012   Eloxatin (OXALIplatin injection) 100mg vial BH07 06/ 2012   Eloxatin (OXALIplatin injection) 100mg vial BH08 06/ 2012  Eloxatin (OXALIplatin injection) 100mg vial BH09 06/ 2012   Eloxatin (OXALIplatin injection) 100mg vial CC109B 01/ 2014
Crispy by TWI Foods Almond Cake Rusk, Biscuit, Net Wt 26.4 oz. Product of Canada Manufactured by TWI Foods Inc. 1869 Gage Court , Mississauga, Ont, Canada . L5S 1S3
UPC 627265002176 with best by dates up to March 27, 2013
Crispy by TWI Foods Coconut Cookies,  Net Wt 7 oz., Product of Canada Manufactured by TWI Foods Inc. 2600 Drew Road, Mississauga, Ont, Canada L4T 3M5.
UPC 627265005214 with best by dates up to March 27, 2013
Crispy by TWI Foods Almond Cookies, Biscuit, Net Wt 7 oz., Product of Canada Manufactured by TWI Foods Inc. 1869 Gage Court, Mississauga, Ont, Canada L5S 1S3
UPC 6 27265 005221 6; All codes, best before March 29, 2013.
Crispy by TWI Foods Pistachio Cookies, Biscuit, Net Wt 7 oz. Product of Canada Manufactured by TWI Foods Inc. 1869 Gage Court, Mississauga, Ont, Canada L5S 1S3.
UPC 6 27265 00161 2; All codes, best before March 29, 2013.
Products may contain undeclared milkand almonds.
Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880  NDC #  00591-0369-01.
Labeling: Incorrect or Missing Package Insert:  An outdated version of a patient outsert was used when packaged.
Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 Rx only. NDC #  0591-0370-01
Loxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880  NDC #  0591-0371-01
Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC #  0591-0372-01
Loxitane Capsules, Loxapine Succinate Capsules,  10mg base, 100 count bottle, Rx only,  Watson Laboratories Inc., Corona, CA 92880 NDC #  52544-495-01
Frozen Oysters, Net Wt 1 LBS (454g).   Distributed by: Seoul Shik Poom, Engleside, NJ.  Origin: Republic of Korea.
All Korean oysters that has the Choripdong Label on it.
Korean Certified Shippers delisted from ICSSL.
Frozen Salted Clam, 12/210g.   Distributed by: Seoul Shik Poom, Engleside, NJ.  Origin: Republic of Korea.
Frozen salted clam, 12/210g; Item # MB3023.
Healthy Choice/Island Blends, Inc. (dba Juice Connection)
Carrot juice. Labeling reads in part:''***LIQUID GOLD 24K CARROT JUICE***JUICE CONNECTION LOS ANGELES CALIFORNIA 90058*** 7 62313 00130 0***INGREDIENTS: PASTEURIZED CARROT JUICE***''.
The firm's carrot juice has the potential to be contaminated with Clostridium botulinum.
Product was distributed within the United States to AL, DE, GA, MA, MI, NC, and VA.  Approximately 75% is still within the firm's control.
Rosati Cry Baby Sour Watermelon water ice, 6 fl oz
Product label does not declare FD&C Yellow #5
retail bakery and restaurants in Wayne, Oakland and Macomb counties of Michigan
Cedar's Bakery Pita Bread, 10 loaves, White; ingredients flour water,yeast, sugar,  salt.  Nt. Wt. 22 oz.(1 lb. 6 oz. - 624 GMs)
Cedar's  Bakery White Pita Bread, does not list the source of the flour ingredient  as wheat, an allergen.
Whole Oysters: 1) Empress Whole Oysters, NET WT 8 OZ.  Distributed By Mitsui Foods Inc. Norwood NJ 07648 Product of Korea, UPC 7360000719. 2) Premium Quality Private Selection Whole Oysters, NET WT 8 OZ.  Distributed By Inter-American Products, Inc. Cincinnati, OH 45202.  Product of Korea, UPC 111081484.
20,074 cases Empress products: 77,437 Private Select products
As of May 1, Korean shellfish imports have been blocked by the United States because Korean waters may have been polluted.  FDA said that all Korean certified shippers of molluscan shellfish were removed from the Interstate Certified Shellfish Shippers List.  Therefore, FDA said that food distributors, retailers and food service operators should ''remove from sale or service, all fresh, frozen and processed Korean molluscan shellfish and any product subsequently made with them.''  Out of an abundance of caution, Mitsui Foods is requesting the return of all Korean oyster product that you may have on hand.
Smoked Oysters: 1) Empress Smoked Oysters In Cottonseed Oil, NET WT 3.75 OZ.  Distributed By Mitsui Foods Inc. Norwood NJ 07648 Product of Korea, UPC7360000713. 2) Premium Quality Private Selection Smoked Oysters In Cottonseed Oil, NET WT 3.75 OZ.  Distributed By Mitsui Foods Inc. Norwood NJ 07648 Product of Korea.  Farm Raised, UPC 111081484.
Private Select brand products: 77,437 cases; Empress 20,074
Super Colon Cleanse, stimulant laxative, 140 mg of Senna per capsule, 25 doses, 100 capsules, Manufactured by: healthPLUS Inc. Chino, CA 91710 USA.
Lot number 120502276, Expiration date 05/2015, UPC Code 08807/11/0 -- revision number 08807/11/0.   Lot number 120201286, Expiration date 03/2015, UPC Code 08807/11/0.
Labeling: Label Mix-up:  The product is being recalled because active ingredient in the Drug Facts box incorrectly states ''Active Ingredients per dose'' Senna Leaf powder 140 mg.  It should correctly be stated as ''Active ingredient (in each capsule)'' Senna Leaf Powder 140 mg.It should correctly be stated as Active ingredient (in each capsule)  Senna Leaf Powder 140 mg.
Nationwide Distribution including IL, MS, OH, PA, TN and VA.
Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one.   The Quick shield Complete Plus is intended to be used only with Vacuette Blood collection Tubes as a system in routine venipuncture procedures. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with instructions for use.
19.5 cases (5,850 pieces) and 244 cases (73,200 pieces)= 263.5 (73258 pieces total)
: The Quickshield Complete Plus may have a defect (split at the base), which can cause the green safety shield attachment of the Quickshield holder to be loose and unstable.
Products were distributed to Oregon and Washington
Cho-Rip-Dong Frozen Oysters in plastic bags: 1) Item no. BG1501, net wt. 1 lb.; 2) Item no. BG1521, net wt. 8 oz.; 3) Item no. BG1551, net wt. 3 lb.; 4) Item no. BG1601, net wt. 10 lb.; 5) Item no. BG1631, net wt. 1 lb.
Korean oysters have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Nol-Boo Global Frozen Rice Cake & Mussel, Item no. EN5011, package in a plastic bag, net wt. 1.21 lb.
product containing mussel has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Na-Rae NR, Salted & Fermented Oyster, item no. MA1159, net wt. 44 lb per case. Cho-Rip-Dong Salted & Fermented Oyster, item no. MB3025, net wt. 7.4 oz per bag.
33 cases/44 lbs and 3 cases/12 pkg/7.4 oz.
product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.