BEUDAMED
    FDA Enforcement Class II Terminated

    Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, 15 G Aspiration Needle (Adjustable Length 15/16" -1-7/8") (24mm-48mm) sterile, For Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion. Original Jamshidi" Bone Marrow Biopsy/Aspiration Needle: - also referred to as Jamshidi needle Intended use for the posterior iliac crest biopsy technique

    Recall: Z-0153-2022 · Reported October 27, 2021

    Enforcement

    Recall Number
    Z-0153-2022
    Event ID
    88674
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bard Peripheral Vascular Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 27, 2021
    Initiation Date
    August 24, 2021
    Classification Date
    October 19, 2021
    Termination Date
    December 23, 2024
    Address
    1625 W 3rd St Bldg 1, N/A, Tempe, AZ, 85281-2438, United States

    Description

    Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, 15 G Aspiration Needle (Adjustable Length 15/16" -1-7/8") (24mm-48mm) sterile, For Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion. Original Jamshidi" Bone Marrow Biopsy/Aspiration Needle: - also referred to as Jamshidi needle Intended use for the posterior iliac crest biopsy technique

    Reason

    Due to misbranded products shipped to customers.

    Code Info

    Cat No.: BEK4511; Lot /Serial No.: 0001379055; UDI # (01)50885403057265(17)211231(10)0001379055;

    Distribution

    U.S. Distribution: CA, GA,HI, IL, IN, LA, MO, MS, NC, OH, PA, PR, TX, UT, VA, and WA. OUS: None

    Quantity

    360 devices