BEUDAMED
    FDA Recall Terminated

    Catalog Number: 900080 CYSTOSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    Recall: Z-1407-2016 · Initiated January 7, 2016

    Recall

    Recall Number
    Z-1407-2016
    Event Number
    72992
    Firm
    Customed, Inc Calle Igualdad Final # 7
    FEI Number
    2648727
    Product Code
    FAJ
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    January 7, 2016
    Posted
    April 14, 2016
    Terminated
    May 3, 2017
    Address
    Fajardo, PR, 00738

    Description

    Catalog Number: 900080 CYSTOSCOPY SURGICAL PACK 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.

    Action

    Recall Notification Letter sent to direct accounts via certified mail with return receipt on January 7, 2016 and January 8, 2016.

    Distribution

    Distributed only in Puerto Rico.

    Quantity

    140