BEUDAMED
    FDA Recall Open, Classified

    Turbett Surgical Container, TS1500

    Recall: Z-1111-2022 · Initiated April 1, 2022

    Recall

    Recall Number
    Z-1111-2022
    Event Number
    90132
    Firm
    TURBETT SURGICAL, LLC
    FEI Number
    3012421755
    Product Code
    FRG
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    April 1, 2022
    Posted
    May 18, 2022
    Address
    668b Phillips Rd, Ofc 1, Victor, NY, 14564-9741

    Description

    Turbett Surgical Container, TS1500

    Reason

    Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use.

    Action

    Firm notified customers on April 1, 2022 via email. Customers were instructed to immediately discontinue use of the product and quarantine the product.

    Distribution

    Domestic distribution to PA, CA, and NY only.

    Quantity

    232 units