BEUDAMED
    FDA Recall Terminated

    BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608

    Recall: Z-0252-2020 · Initiated March 7, 2019

    Recall

    Recall Number
    Z-0252-2020
    Event Number
    82351
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    FMI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 7, 2019
    Posted
    October 31, 2019
    Terminated
    February 11, 2022
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608

    Reason

    BD PAS received customer complaints indicating the absence of the bevel on the non-patient needle end of the product, causing blood leakage.

    Action

    On March 7, 2019, the firm distributed Urgent Medical Device Recall letters to customers. Customers were informed of the missing bevel, which may ultimately cause leakage if the needle damages the sleeve. ***UPDATED 7/11/19*** In July 2019, the firm sent out an additional notice, informing customers that two additional lots of the product were found to also be affected by the recall. ***UPDATED 12/10/19*** ON 12/4/19, the firm sent out a second expansion letter, informing that customers that an additional lot of product (lot 9010765) was also found to be missing the bevel from the non-patient needle end of the product. ***END UPDATE*** Customers were asked to take the following actions: 1. Immediately review your inventory for the specific Catalogue (Ref) and lot number listed above. Destroy all product subject to the recall following your institutions process for destruction. 2. Share this recall notification with all users of the product within your facility to ensure that they are also aware of this recall. 3. Complete the attached Customer Response Forms 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. The firm stated it would provide replacement for all discarded inventory. ***PUBLIC CONTACT ADDED 7/11/19*** If you have any questions, you may reach BD Customer/Technical Support at 888-237-2762 OPT 3, OPT 2; Monday Friday 8:00am - 5:00pm (CT)

    Distribution

    Distributed to accounts in AR, CT, FL, IL, IN, MI, MO, MS, NY, OH, TN, TX, and VA. Foreign distribution to Canada, Brazil, India, Mexico, Singapore, and Taiwan.

    Quantity

    2,624,160 (2,169,703 US; 454,457 OUS)