BEUDAMED
    FDA Recall Open, Classified

    WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965 Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips

    Recall: Z-0497-2020 · Initiated October 4, 2019

    Recall

    Recall Number
    Z-0497-2020
    Event Number
    84032
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    FZP
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 4, 2019
    Address
    3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437

    Description

    WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965 Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips

    Reason

    Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips falling out of the applier, clip breakage, or the jaws becoming locked in a partially closed position (jammed).

    Action

    The firm notified their consignees by letter on 10/04/2019. The letter explained the issue and requested the user discontinue use and contact the company for instructions for their return. Distributors were directed to notify their customers and collect the affected product for return to Teleflex Medical.

    Distribution

    Worldwide distribution, including US nationwide (including Puerto Rico).

    Quantity

    4099 devices