BEUDAMED
    FDA Enforcement Class II Terminated

    5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer

    Recall: Z-1991-2021 · Reported July 7, 2021

    Enforcement

    Recall Number
    Z-1991-2021
    Event ID
    88048
    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
    June 30, 2021
    Termination Date
    January 24, 2023
    Address
    605 N 5600 W, N/A, Salt Lake City, UT, 84116-3738, United States

    Description

    5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer

    Reason

    Catheter kits contained the incorrect micro-introducers.

    Code Info

    Catalog Number: 3175155 UDI Code: (01)00801741027680 Lot Number: REEU0201

    Distribution

    U.S.: CT, GA, MA, MI, MT, NJ, NV, NY, VA, and WI. O.U.S.: None

    Quantity

    180 units