BEUDAMED
    FDA Enforcement Class II Terminated

    OPEN HEART TRAY 1/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    Recall: Z-2581-2015 · Reported September 9, 2015

    Enforcement

    Recall Number
    Z-2581-2015
    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

    OPEN HEART TRAY 1/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:9001393 Lots: 141116010 exp. 12/31/15 150217555 exp. 12/31/15 150217554 exp. 12/31/15 150418441 exp. 4/30/16 150418442 exp. 4/30/16 150518900 exp. 6/30/16

    Distribution

    Distributed Only in Puerto Rico.

    Quantity

    56 trays