BEUDAMED
    FDA Recall Terminated

    BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administration of a drug from a cartridge contained in a drug pen injector Catalog Number: 320122

    Recall: Z-0508-2021 · Initiated October 23, 2020

    Recall

    Recall Number
    Z-0508-2021
    Event Number
    86679
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    FMI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 23, 2020
    Terminated
    September 8, 2023
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administration of a drug from a cartridge contained in a drug pen injector Catalog Number: 320122

    Reason

    Product shelf cartons incorrectly labeled as products intended for the Latin American market. Although the product description on the label 32G x 4mm pen needles is correct, information pertinent to users in the US regarding compatibility with specific pen needles is missing.

    Action

    BD consignees and distributors notified on October 23, 2020 via hard copy letter sent via Federal Express (FedEx) and/or email, when available. Letter states reason for recall, health risk and action to take: 1. Immediately review your inventory for the specific Catalog (Ref) and Lot number specified in this notification and discard all product subject to the recall. 2. Share this recall notification with pharmacy staff at all applicable pharmacy locations and display the letter where it is visible to all to ensure awareness of this recall Distributors are requested to identify their customers and provide BD a customer list. BD will notify these customers via FedEx. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your product replacement order, accordingly. 4. This recall is being conducted at the wholesaler/hospital/retail level only. There is no need to notify users who may have already purchased the device, as the product itself is not defective and presents no risk to users. Actions Taken by BD: " Replacement product will be provided for all discarded inventory. Contact Information: If you require further assistance, please contact: BD Contact Information: BD Customer/Technical Support (844) 823-5433 Mon Fri 8:30am - 5:00pm (CST

    Distribution

    Nationwide

    Quantity

    2,881,200 units