BEUDAMED
    FDA Recall Open, Classified

    injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25 gauge

    Recall: Z-1478-2023 · Initiated February 7, 2023

    Recall

    Recall Number
    Z-1478-2023
    Event Number
    91831
    Firm
    Labories Medical Technologies
    FEI Number
    3017448360
    Product Code
    FBK
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    February 7, 2023
    Posted
    April 28, 2023
    Address
    180 International Dr, Portsmouth, NH, 03801-6837

    Description

    injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25 gauge

    Reason

    The packaging may be damaged, compromising the sterile barrier.

    Action

    A customer letter dated February 7, 2023 was issued to impacted consignees. The letter asks consignees to examine their inventory for affected product lots and to complete a response card to the recalling firm. Return of impacted product will be coordinated with Laborie Medical Technologies.

    Distribution

    Worldwide distribution.

    Quantity

    415,480 units