BEUDAMED
    FDA Enforcement Class II Terminated

    BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampoules and parts of the body below the surface of the skin.

    Recall: Z-0588-2021 · Reported December 23, 2020

    Enforcement

    Recall Number
    Z-0588-2021
    Event ID
    86857
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 23, 2020
    Initiation Date
    November 18, 2020
    Classification Date
    December 15, 2020
    Termination Date
    February 15, 2024
    Address
    1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampoules and parts of the body below the surface of the skin.

    Reason

    BD has confirmed the presence of blood on the cannulas of the BD PrecisionGlide needles 30G X 1/2" Lot No. 9128897. The possibility of infection may be present if the blood is not noticed prior to use by the clinician.

    Code Info

    Catalog Ref No.: 305106 Lot No:. 9128897 Expiration Date: 2024-06-30 UDI: 30382903051060 Product Package Size: 100 units per carton

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of CA, CT, FL, IL, KY, MO, NJ, NY, OH, PA, PR, SC, TN, VA and the countries of Canada, China, Singapore.

    Quantity

    1,430,000