BEUDAMED
    FDA Enforcement Class II Terminated

    Catalog Number: 900521 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, X-LARGE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    Recall: Z-1474-2016 · Reported April 20, 2016

    Enforcement

    Recall Number
    Z-1474-2016
    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: 900521 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, X-LARGE 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: SV15168 (150418240) 30-APR-16 SL15209 (150719850) 31-JUL-16 SL15218 (150719850) 31-JUL-16 SL15229 (150719850) 31-JUL-16 SL15244 (150820336) 31-AUG-16 SL15251 (150719850) 31-JUL-16 SL15252 (150719850) 31-JUL-16 SL15254 (150719850) 31-JUL-16 SL15254 (150820336) 31-AUG-16 SL15257 (150820336) 31-AUG-16 SL15258 (150820336) 31-AUG-16

    Distribution

    Distributed only in Puerto Rico.

    Quantity

    5712