BEUDAMED
    FDA Enforcement Class II Terminated

    Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135

    Recall: Z-2337-2018 · Reported July 11, 2018

    Enforcement

    Recall Number
    Z-2337-2018
    Event ID
    80242
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Medical Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 11, 2018
    Initiation Date
    April 9, 2018
    Classification Date
    June 29, 2018
    Termination Date
    April 19, 2019
    Address
    2101 Cottontail Ln, Somerset, NJ, 08873-1277, United States

    Description

    Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135

    Reason

    Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. Although sterile, products from these lots may not function as intended and therefore should not be used.

    Code Info

    5980075, 5980077

    Distribution

    Distributed to accounts in AL, CA, FL, IA, IN, MI, MO, NC, NY, SD, TN, and TX.

    Quantity

    240