BEUDAMED
    FDA Enforcement Class I Terminated

    Laparotomy Pack, Catalog # 900-996 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    Recall: Z-0413-2015 · Reported December 10, 2014

    Enforcement

    Recall Number
    Z-0413-2015
    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

    Laparotomy Pack, Catalog # 900-996 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    Reason

    Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

    Code Info

    Lot numbers 140513385 140513485 140613851 140814554 140814964 140915188

    Distribution

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

    Quantity

    372