BEUDAMED
    FDA Enforcement Class I Terminated

    Surgical packs (includes trays, bags and kits) Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    Recall: Z-0237-2015 · Reported December 10, 2014

    Enforcement

    Recall Number
    Z-0237-2015
    Event ID
    69448
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Customed, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 10, 2014
    Initiation Date
    October 8, 2014
    Classification Date
    November 28, 2014
    Termination Date
    August 14, 2017
    Address
    Calle Igualdad Final #7, N/A, Fajardo, PR, 00738, United States

    Description

    Surgical packs (includes trays, bags and kits) Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    Reason

    Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes (QSR) and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

    Code Info

    Lot numbers 111102811 111112953 111112969 111123257 111123438 112010003 112020291 112030762 112041051 112041384 112051641 112051718 112062298 112072758 112083040 112104122 112104289 112114540 112124364 112124885 113025838 113026102 113026206 113057390 113057682 113099556 131010023 131210663 140111103 140412874 140513047 140513388 140613946 140714499 140815022

    Distribution

    US Distribution to Florida, New York and Puerto Rico..

    Quantity

    185000