BEUDAMED
    FDA Recall Open, Classified

    Hobbs Medical Polypectomy Snare, Catalog No. 7202

    Recall: Z-1388-2022 · Initiated June 3, 2022

    Recall

    Recall Number
    Z-1388-2022
    Event Number
    90456
    Firm
    Hobbs Medical, Inc.
    FEI Number
    1220592
    Product Code
    OCZ
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    June 3, 2022
    Address
    8 Spring St, Stafford Springs, CT, 06076-1505

    Description

    Hobbs Medical Polypectomy Snare, Catalog No. 7202

    Reason

    During use, the sheath of the device may accordion at the proximal end where the sheath meets the shrink band. Kinking of the sheath may prevent the snare from fully closing, and injury may result.

    Action

    On June 3, 2022, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were instructed to immediately cease use of the affected product and to return the product to Hobbs Medical. For questions related to the Acknowledgement Form and its return, please contact Hobbs Customer Service at 1-800-344-6227

    Distribution

    Domestic distribution to NC, TX, and WA. Foreign distribution to Canada.

    Quantity

    45 (US)