BEUDAMED
    FDA Enforcement Class II Terminated

    5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD MYPICC KIT 5F French Size Dual-Lumen 70cm Guidewire

    Recall: Z-1994-2021 · Reported July 7, 2021

    Enforcement

    Recall Number
    Z-1994-2021
    Event ID
    88057
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bard Access Systems Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 7, 2021
    Initiation Date
    May 19, 2021
    Classification Date
    July 1, 2021
    Termination Date
    March 31, 2023
    Address
    605 N 5600 W, N/A, Salt Lake City, UT, 84116-3738, United States

    Description

    5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD MYPICC KIT 5F French Size Dual-Lumen 70cm Guidewire

    Reason

    Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire.

    Code Info

    Catalog (REF) Number: CK000340B UDI Code: (01)00801741126697 Lot Number: 20BBK658

    Distribution

    U.S. Nationwide distribution in the state of RI.

    Quantity

    30 kits