BEUDAMED
    FDA Enforcement Class II Terminated

    STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.

    Recall: Z-2035-2020 · Reported May 27, 2020

    Enforcement

    Recall Number
    Z-2035-2020
    Event ID
    85421
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Applied Medical Resources Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 27, 2020
    Initiation Date
    January 31, 2020
    Classification Date
    May 15, 2020
    Termination Date
    April 20, 2022
    Address
    22872 Avenida Empresa, N/A, Rancho Santa Margarita, CA, 92688-2650, United States

    Description

    STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - 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.

    Code Info

    LOT # 1360356, Manufacture Date July 5, 2019; Expiration Date July 3, 2024

    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