BEUDAMED
    FDA Enforcement Class II Terminated

    Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, sterile, Qty: 10, Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion Intended use to aspirate marrow from either the sternum or the iliac crest. Intraosseous Infusion is recommended only in life-threatening emergencies where vascular access is critical and conventional forms of access are not available or are unobtainable.

    Recall: Z-0154-2022 · Reported October 27, 2021

    Enforcement

    Recall Number
    Z-0154-2022
    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 # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, sterile, Qty: 10, Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion Intended use to aspirate marrow from either the sternum or the iliac crest. Intraosseous Infusion is recommended only in life-threatening emergencies where vascular access is critical and conventional forms of access are not available or are unobtainable.

    Reason

    Due to misbranded products shipped to customers.

    Code Info

    Cat No.: BEK3411; Lot /Serial No.: 0001378561; UDI # BEK3411, Lot BEK3411, Lot BEK3411, Lot 0001378561; (01)50885403057258(17)211231(10)0001378561; Mfg. Date 08/19/2020; Exp. Date: 12/31/2021; Qty: 360

    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