BEUDAMED
    FDA Enforcement Class I Terminated

    LAPAROTOMY PACK - CUSTOMED- (1) BAG SUTURE FLORAL (2) TOWEL ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) DRAPE T LAPAROTOMY STD SMS (2) SHEET DRAPE 42" X 57" (1) TABLE COVER REINFORCED 50" X 90" (4) DRAPE UTILITY WITH TAPE EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents

    Recall: Z-2312-2014 · Reported September 10, 2014

    Enforcement

    Recall Number
    Z-2312-2014
    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 - CUSTOMED- (1) BAG SUTURE FLORAL (2) TOWEL ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) DRAPE T LAPAROTOMY STD SMS (2) SHEET DRAPE 42" X 57" (1) TABLE COVER REINFORCED 50" X 90" (4) DRAPE UTILITY WITH TAPE 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

    Product code 900-176, 48 lots: 110030643 110040905 110081992 111020467 111020499 111030609 111030830 111030932 111051336 111051472 111061512 111071910 111072024 111082068 111092366 111092455 111102645 111112937 111113036 111113163 111123386 111123476 112010091 112010247 112010272 112010285 112020410 112020565 112020570 112030693 112030890 112031006 112041370 112051553 112051879 112062449 112062566 112083377 113099568 131110070 131110404 131110581 131210965 140111413 140211741 140312333 140412794 140513112

    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

    48 lots; 15008 units (multiple units per lot)