BEUDAMED
    FDA Recall Terminated

    FIRMap" Catheter, 60mm Basket

    Recall: Z-1213-2022 · Initiated April 28, 2022

    Recall

    Recall Number
    Z-1213-2022
    Event Number
    90106
    Firm
    Abbott
    FEI Number
    3005334138
    Product Code
    MTD
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 28, 2022
    Terminated
    June 18, 2024
    Address
    5050 Nathan Ln N, Plymouth, MN, 55442-3209

    Description

    FIRMap" Catheter, 60mm Basket

    Reason

    Incorrect product labeling.

    Action

    The firm sent out a "MEDICAL DEVICE RECALL" notification letter dated 04/28/2022 via hand delivery to the US customers. OUS consignee notification is via hand delivery. A copy of the English version of the OUS letter is attached and this letter was translated into the appropriate languages for delivery. The letter instructs the consignee to stop using the remaining inventory, complete and return the acknowledgement form by email: [email protected], and return all unused devices. Should you have questions about this issue, please contact your local Abbott Representative or Abbot Support at 1-888-655-3500 (Option 2) (U.S.), 8:30 a.m. - 5:30 p.m. Central Time Monday through Friday.

    Distribution

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

    Quantity

    40 units