BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported June 7, 2023

    Enforcement

    Recall Number
    Z-1663-2023
    Event ID
    92212
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    TELEFLEX LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 7, 2023
    Initiation Date
    April 28, 2023
    Classification Date
    May 30, 2023
    Address
    3015 Carrington Mill Blvd, N/A, Morrisville, NC, 27560-5437, United States

    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.

    Code Info

    UDI/DI 24026704696394, Lot Numbers: 73A2200857, 73A2300018, 73A2300176, 73A2300326, 73A2300520, 73A2300778, 73D2200216, 73D2200559, 73E2200634, 73E2200874, 73E2201099, 73F2200193, 73F2200200, 73F2200482, 73F2200711, 73G2200168, 73G2200345, 73G2200560, 73G2200754, 73H2200115, 73H2200294, 73H2200433, 73H2200453, 73J2200747, 73J2200763, 73K2200014, 73K2200095, 73K2200101, 73K2200299, 73K2200566, 73K2200713, 73L2200064, 73L2200066

    Distribution

    worldwide

    Quantity

    146,606 units