BEUDAMED
    FDA Recall 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 · Initiated October 29, 2021

    Recall

    Recall Number
    Z-1771-2022
    Event Number
    90776
    Firm
    Diversatek Healthcare
    FEI Number
    2183446
    Product Code
    FGX
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    October 29, 2021
    Terminated
    April 10, 2024
    Address
    102 E Keefe Ave, Milwaukee, WI, 53212-1535

    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.

    Distribution

    US Nationwide distribution.

    Quantity

    245 devices