BEUDAMED
    FDA Recall Terminated

    STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.

    Recall: Z-2036-2020 · Initiated January 31, 2020

    Recall

    Recall Number
    Z-2036-2020
    Event Number
    85421
    Firm
    Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa
    FEI Number
    2027111
    Product Code
    DSS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 31, 2020
    Terminated
    April 20, 2022
    Address
    Margarita, CA, 92688-2650

    Description

    STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.

    Reason

    Failure of cardiovascular clips to provide sufficient occlusion of the vessel.

    Action

    On 01/31/2020, Customer Notification Letter was sent to all consignees/ distributors requesting them to return the affected devices to the recalling firm.

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KY, MA, MI, MO, NC, NE, NJ, NY, OK, PA, TN, TX, UT, VA. WA and WI. The countries of Austria, Australia, Canada, Switzerland, Germany, Spain, Finland, France, Italy, Japan, Mexico, and Netherlands.

    Quantity

    2240 units