BEUDAMED
    FDA Enforcement Class II Terminated

    Catalog Number: 9001574 LEGGINS 30X42 W/7" CUFF Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    Recall: Z-1430-2016 · Reported April 20, 2016

    Enforcement

    Recall Number
    Z-1430-2016
    Event ID
    72992
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Customed, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 20, 2016
    Initiation Date
    January 7, 2016
    Classification Date
    April 14, 2016
    Termination Date
    May 3, 2017
    Address
    Calle Igualdad Final #7, N/A, Fajardo, PR, 00738, United States

    Description

    Catalog Number: 9001574 LEGGINS 30X42 W/7" CUFF 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

    LOTS: SL15194 (150719656) 31-JUL-16 SL15223 (150820181) 31-AUG-16 SL15223 (150820180) 31-AUG-16 SL15223 (150820182) 31-AUG-16

    Distribution

    Distributed only in Puerto Rico.

    Quantity

    270