BEUDAMED
    FDA Enforcement Class II Terminated

    Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically retrieve severed polyps, tissue samples, food bolus, and foreign bodies in the gastrointestinal tract.

    Recall: Z-1771-2022 · Reported September 28, 2022

    Enforcement

    Recall Number
    Z-1771-2022
    Event ID
    90776
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Diversatek Healthcare
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 28, 2022
    Initiation Date
    October 29, 2021
    Classification Date
    September 19, 2022
    Termination Date
    April 10, 2024
    Address
    102 E Keefe Ave, N/A, Milwaukee, WI, 53212-1535, United States

    Description

    Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically retrieve severed polyps, tissue samples, food bolus, and foreign bodies in the gastrointestinal tract.

    Reason

    M-Catch Retrieval Nets, Part Number 1175-01 / Lot Number 001919, that were shipped between 9-27-2021 and 10-22-2021, may contain incorrect inner polybag labeling. The outer package labeling is correct.

    Code Info

    UDI/DI 00816734021361, lot number 001919, 2024-10-31, shipped between 9-27-2021 and 10-22-2021.

    Distribution

    US Nationwide distribution.

    Quantity

    245 devices