BEUDAMED
    FDA Enforcement Class II Terminated

    FIRMap" Catheter, 60mm Basket

    Recall: Z-1213-2022 · Reported June 8, 2022

    Enforcement

    Recall Number
    Z-1213-2022
    Event ID
    90106
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 8, 2022
    Initiation Date
    April 28, 2022
    Classification Date
    June 1, 2022
    Termination Date
    June 18, 2024
    Address
    5050 Nathan Ln N, N/A, Plymouth, MN, 55442-3209, United States

    Description

    FIRMap" Catheter, 60mm Basket

    Reason

    Incorrect product labeling.

    Code Info

    Model Number: AR064060; UDI Number: ( 01) 0 0810591 02002 4 ( 17) 020531 ( 00) 1 2345678 95; Batch Numbers: 2158303 (Exp. Date: 30 NOV 2022), 2159876 (Exp. Date: 31 JAN 2023), 2156510 (Exp. Date: 30 SEP 2022), 2162996 (Exp. Date: 31 MAR 2023), 2159875 (Exp. Date: 30 NOV 2022), and 2159877 ( Exp. Date: 30 NOV 2022).

    Distribution

    US Nationwide Distribution to states of: MO, CA, OH, WA and OUS internationally to Italy and Netherlands.

    Quantity

    40 units