BEUDAMED
    FDA Enforcement Class II Terminated

    ANGIOGRAPHY PACK CUSTOMED 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    Recall: Z-2622-2015 · Reported September 9, 2015

    Enforcement

    Recall Number
    Z-2622-2015
    Event ID
    71721
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Customed, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 9, 2015
    Initiation Date
    July 10, 2015
    Classification Date
    September 3, 2015
    Termination Date
    April 12, 2017
    Address
    Calle Igualdad Final #7, N/A, Fajardo, PR, 00738, United States

    Description

    ANGIOGRAPHY PACK CUSTOMED 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    Reason

    Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

    Code Info

    Code:900210 Lots: 140915501 exp. 10/31/15 140915501 exp. 10/31/15 150116702 exp. 2/28/16 150116701 exp. 1/31/16 150116703 exp. 1/31/16 150116704 exp. 1/31/16 150116705 exp. 1/31/16 150116706 exp. 1/31/16 150217378 exp. 2/28/16 150217379 exp. 2/28/16 150217380 exp. 2/28/16 150217381 exp. 2/28/16 150217382 exp. 2/28/16 150317721 exp. 3/31/16 150317720 exp. 3/31/16 150318115 exp. 3/31/16 150318116 exp. 3/31/16 150318117 exp. 3/31/16 150318118 exp. 3/31/16 150418270 exp. 4/30/16 150418271 exp. 4/30/16 150418272 exp. 4/30/16 150418273 exp. 4/30/16

    Distribution

    Distributed Only in Puerto Rico.

    Quantity

    1128