BEUDAMED
    FDA Enforcement Class II Terminated

    Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery

    Recall: Z-2538-2016 · Reported August 24, 2016

    Enforcement

    Recall Number
    Z-2538-2016
    Event ID
    74683
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 24, 2016
    Initiation Date
    March 24, 2016
    Classification Date
    August 15, 2016
    Termination Date
    September 25, 2020
    Address
    2917 Weck Dr, N/A, Research Triangle Park, NC, 27709-0186, United States

    Description

    Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery

    Reason

    Incorrect expiration date was printed on the product label.

    Code Info

    Product Code EFXCT1 - Lot/Batch Nos. ML-000342, ML-000343, ML-000344, ML-000348, ML-000349; Product Code EFXSP1 - Lot/Batch Nos. ML-000345, ML-000347

    Distribution

    Nationwide Distribution to CA, CO, IA, KS, MD, MI, NY, NC, PA

    Quantity

    45