BEUDAMED
    FDA Enforcement Class III Terminated

    FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model number : USAR064060 Sterile, Rx only Cardiovascular: For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.

    Recall: Z-2478-2015 · Reported September 9, 2015

    Enforcement

    Recall Number
    Z-2478-2015
    Event ID
    71970
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Electrophysiology
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 9, 2015
    Initiation Date
    August 12, 2015
    Classification Date
    August 28, 2015
    Termination Date
    September 23, 2015
    Address
    1530 Obrien Dr, N/A, Menlo Park, CA, 94025-1454, United States

    Description

    FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model number : USAR064060 Sterile, Rx only Cardiovascular: For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.

    Reason

    The expiration date was incorrectly printed on the pouch/box labels of 19 products that were shipped to customer sites. The manufacturing date was accidentally used (copied) for the expiration date.

    Code Info

    Model number : USAR064060; Lot code: TPR031615-01

    Distribution

    US Distribution in states of: KY, IN, MO, NY, OH, TX, LA, IL, PA, NJ, WA, VA, FL, GA, CT, CA, AZ, CO, and TN.

    Quantity

    86 units