BEUDAMED
    FDA Recall Completed

    Vaginal Rejuvenation Pack - contains Devon Light Glove Used during surgery

    Recall: Z-2001-2015 · Initiated April 20, 2015

    Recall

    Recall Number
    Z-2001-2015
    Event Number
    71130
    Firm
    Stradis Healthcare, LLC.
    FEI Number
    1000111025
    Product Code
    LRO
    Status
    Completed
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 20, 2015
    Posted
    July 7, 2015
    Address
    805 Marathon Pkwy, Ste 100, Lawrenceville, GA, 30046-2885

    Description

    Vaginal Rejuvenation Pack - contains Devon Light Glove Used during surgery

    Reason

    Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

    Action

    Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to [email protected]. Customers with questions regarding return of the product should call 1-727-642--4124.

    Distribution

    Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai

    Quantity

    One