BEUDAMED
    FDA Enforcement Class I Terminated

    LAPAROTOMY PACK BASIC CODE 900-2829 CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (1) COVER MAYO STAND REINFORCED (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) DRAPE T LAPAROT 102" X 78" X 121" STD SMS (1) COVER TABLE REINFORCED 50" X 90" (1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI LEVEL Ill (1) TIME OUT BEACON NON WOVEN (1) COUNTER NDUBLADE 20C FOAM/MAG (1) SKIN MARKER INK W/8 LABEUTIME OUT/RULER (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL & WRAP AAMI LEVEL Ill Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    Recall: Z-2506-2014 · Reported September 10, 2014

    Enforcement

    Recall Number
    Z-2506-2014
    Event ID
    68536
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Customed, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 10, 2014
    Initiation Date
    May 20, 2014
    Classification Date
    August 29, 2014
    Termination Date
    August 14, 2017
    Address
    Calle Igualdad Final #7, Fajardo, PR, 00738, United States

    Description

    LAPAROTOMY PACK BASIC CODE 900-2829 CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (1) COVER MAYO STAND REINFORCED (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) DRAPE T LAPAROT 102" X 78" X 121" STD SMS (1) COVER TABLE REINFORCED 50" X 90" (1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI LEVEL Ill (1) TIME OUT BEACON NON WOVEN (1) COUNTER NDUBLADE 20C FOAM/MAG (1) SKIN MARKER INK W/8 LABEUTIME OUT/RULER (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL & WRAP AAMI LEVEL Ill 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.

    Code Info

    Code 900-2829, 4 lots 140111331 140211831 140312145 140412671

    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

    4 lots, 360 units ( multiple units per lot)