BEUDAMED
    FDA Recall Terminated

    Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.

    Recall: Z-1193-2018 · Initiated February 15, 2018

    Recall

    Recall Number
    Z-1193-2018
    Event Number
    79301
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    GDT
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    February 15, 2018
    Terminated
    October 31, 2018
    Address
    2917 Weck Dr, Research Triangle Park, NC, 27709-0186

    Description

    Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.

    Reason

    Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular devices. The 6 individually packaged units within the boxes are correctly labeled.

    Action

    The firm initiated the recall on 02/14/2018 by letter and followed up with another letter on 03/12/2018 to clarify the labeling issue. The letter to the distributor stated: "1. Immediately discontinue distribution and quarantine any products with the catalog and lot number listed above. 2. Inspect affected products within your control to identify if the box label correctly identifies the products inside the box. Products with an incorrect label on the box should be returned to Teleflex Medical so that they are not distributed to health care providers in error. 3. Using the provided Customer Letter and Acknowledgement Form templates, communicate this recall to any of your customers who have received product included within the scope of the recall. Customers may return mislabeled products if they choose to do so. Note the attached Customer Letter template was updated since this letter was first sent to you. 4. If any of your customers wish to return affected products, have them return the affected products to you, together with a completed Acknowledgement Form, for consolidation and return to Teleflex Medical. In the event that an alternative approach is needed, contact Teleflex Customer Service for more information at 1-866-246-6990." The customer letter requested discontinuation of use and quarantining of products and return of affected stock.

    Distribution

    KS

    Quantity

    12 units