BEUDAMED
    FDA Recall Open, Classified

    Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that require vessel or tissue ligation

    Recall: Z-1663-2023 · Initiated April 28, 2023

    Recall

    Recall Number
    Z-1663-2023
    Event Number
    92212
    Firm
    TELEFLEX LLC
    FEI Number
    3005747797
    Product Code
    FZP
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 28, 2023
    Posted
    May 30, 2023
    Address
    3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437

    Description

    Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that require vessel or tissue ligation

    Reason

    Teleflex LLC is initiating this voluntary field corrective action because the clip cartridges for the affected product is missing a key feature that restricts the application of the clip to the applier. With this step feature missing on the cartridge, the clip is mounted in a more variable position, allowing the clips to load farther back in the clip applier jaw grooves. This may potentially result in inappropriate or inadequate clip application to vascular structures.

    Action

    Teleflex issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 04/28/2023 by FedEx 2nd day mail. The letter explained the issue, potential risk, and requested the following actions: Medical facilities: Cease use and distribution, and isolate the affected product. Circulate the notice to all affected departments. Distributors: Cease use and distribution, and isolate the affected product. Provide the notice to your customers. Teleflex is seeking return of the affected units.

    Distribution

    worldwide

    Quantity

    146,606 units