BEUDAMED
    FDA Enforcement Class II Ongoing

    Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7045; endoscopic surgical device

    Recall: Z-2421-2023 · Reported August 23, 2023

    Enforcement

    Recall Number
    Z-2421-2023
    Event ID
    92561
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Carefusion 2200 Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    August 23, 2023
    Initiation Date
    July 13, 2023
    Classification Date
    August 17, 2023
    Address
    75 N Fairway Dr, Vernon Hills, IL, 60061-1845, United States

    Description

    Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7045; endoscopic surgical device

    Reason

    Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.

    Code Info

    UDI/DI 10885403160561, Lot Number B23

    Distribution

    US and Canada

    Quantity

    2 units