BEUDAMED
    FDA Recall Terminated

    Endovascular Pack, code 900-2715, contains: ( I) DRAPE FEMORAL ANG. 125 X 75 X 56 WITH POUCH LIF (2) TOWELS ABSORBENT 15 X 20 LIF ( I) CONTAINER SPECIMEN 4oz W/LID & LABEL Llf (2) BAG BAND FLUOROSCOPE 36 X 30 LIF ( I) NEEDLE HYPODERMIC 21G X I Y, LIF (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMI III LIF (2) SOLUTION SURGICAL DURAPREP 6ML LIF ( I) BAG BAND RUB BAND & TAPE 42 X 38 LIF (4) TOWELS CLOTH HUCK BLUE LIF (I) Pr. GLOVE SYNTEGRA CR 6.5 POWDER FREE Llf (2) Pr. GLOVE SYNTEGRA CR 8 POWDER FREE LIF ( I) NEEDLE HYPODERMIC 25G X 5/8 LIF ( I) SYRINGE 30CC WITHOUT NEEDLE LUER LOCK LIF (I) COYER TABLE 44 X 90 LIF ( I) SCALPEL WITH HANDLE (25) GAUZE SPONGES 4 X 4 12PLY LIF (2) CLAMP TOWEL (2) SYRINGE I OCC WITHOUT NEEDLE LUER LOCK LIF ( I) NEEDLE HYPODERMIC 18G X I Y, LIF ( I) SHARP STOP NEEDLE HOLDER LIF ( I) TRAY ORGANIZER FULL DEEP ( I) NEEDLE 18G X 23 (I) BOWL UTILITY BLUE 16oz LIF ( I) WRAPPER 24X 24 LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    Recall: Z-2498-2014 · Initiated May 20, 2014

    Recall

    Recall Number
    Z-2498-2014
    Event Number
    68536
    Firm
    Customed, Inc Calle Igualdad Final # 7
    FEI Number
    2648727
    Product Code
    OFA
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    May 20, 2014
    Posted
    August 29, 2014
    Terminated
    August 14, 2017
    Address
    Fajardo, PR, 00738

    Description

    Endovascular Pack, code 900-2715, contains: ( I) DRAPE FEMORAL ANG. 125 X 75 X 56 WITH POUCH LIF (2) TOWELS ABSORBENT 15 X 20 LIF ( I) CONTAINER SPECIMEN 4oz W/LID & LABEL Llf (2) BAG BAND FLUOROSCOPE 36 X 30 LIF ( I) NEEDLE HYPODERMIC 21G X I Y, LIF (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMI III LIF (2) SOLUTION SURGICAL DURAPREP 6ML LIF ( I) BAG BAND RUB BAND & TAPE 42 X 38 LIF (4) TOWELS CLOTH HUCK BLUE LIF (I) Pr. GLOVE SYNTEGRA CR 6.5 POWDER FREE Llf (2) Pr. GLOVE SYNTEGRA CR 8 POWDER FREE LIF ( I) NEEDLE HYPODERMIC 25G X 5/8 LIF ( I) SYRINGE 30CC WITHOUT NEEDLE LUER LOCK LIF (I) COYER TABLE 44 X 90 LIF ( I) SCALPEL WITH HANDLE (25) GAUZE SPONGES 4 X 4 12PLY LIF (2) CLAMP TOWEL (2) SYRINGE I OCC WITHOUT NEEDLE LUER LOCK LIF ( I) NEEDLE HYPODERMIC 18G X I Y, LIF ( I) SHARP STOP NEEDLE HOLDER LIF ( I) TRAY ORGANIZER FULL DEEP ( I) NEEDLE 18G X 23 (I) BOWL UTILITY BLUE 16oz LIF ( I) WRAPPER 24X 24 LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    Reason

    Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

    Action

    Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit. Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540

    Distribution

    Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.

    Quantity

    1 lot/ 12 units