BEUDAMED
    FDA Enforcement Class II Terminated

    Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be used for the access of a specimen from Catheter Port to BD Vacutainer¿ Blood Collection or Urine Collection Tubes.

    Recall: Z-2393-2021 · Reported September 8, 2021

    Enforcement

    Recall Number
    Z-2393-2021
    Event ID
    88338
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Magnolia Medical Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 8, 2021
    Initiation Date
    August 2, 2021
    Classification Date
    August 31, 2021
    Termination Date
    February 22, 2023
    Address
    200 W Mercer St Ste 500, N/A, Seattle, WA, 98119-5908, United States

    Description

    Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be used for the access of a specimen from Catheter Port to BD Vacutainer¿ Blood Collection or Urine Collection Tubes.

    Reason

    Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU).

    Code Info

    Catalog #: 27BD-EN, Part #: P00165-000 Lot #9448037

    Distribution

    U.S. Nationwide distribution i the states of AL, CO, FL, GA, IL, IN, MD, MI, NE, NY, PA, SC, TX, VA, WV, and WY. O.U.S.: N/A

    Quantity

    9,400 units