BEUDAMED
    FDA Recall 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 · Initiated March 24, 2016

    Recall

    Recall Number
    Z-2538-2016
    Event Number
    74683
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    HCF
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    March 24, 2016
    Terminated
    September 25, 2020
    Address
    2917 Weck Dr, Research Triangle Park, NC, 27709-0186

    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.

    Action

    Teleflex sent an Urgent Medical Device Recall Notification letter dated March 24, 2016, to all affected consignees. The letter requested that consignees check their stock, immediately discontinue use and quarantine any products. To return affected product consignees were instructed to complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, ATTN: Customer Service or email to [email protected]. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990. For questions regarding this recall call 610-378-0131.

    Distribution

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

    Quantity

    45