BEUDAMED
    FDA Recall Terminated

    BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitor Part/Catalog Number: 365992

    Recall: Z-0061-2020 · Initiated May 13, 2019

    Recall

    Recall Number
    Z-0061-2020
    Event Number
    82851
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    JKA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 13, 2019
    Terminated
    August 6, 2020
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitor Part/Catalog Number: 365992

    Reason

    Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.

    Action

    Becton Dickinson (BD) notified consignees affected by letter via UPS and email dated May 13,2019. Letter describes reason for recall, health risk and action to take: 1. Immediately review your inventory for the specific catalog and lot numbers listed below, 2. Destroy all product subject to the recall following your institution's process for destruction, 3. Share this Urgent Medical Device Recall notification with all users of the product to ensure that they are also aware of this recall, and 4. Complete the attached Customer Response/Certificate of Destruction 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. Distributors provide their customer list to BD. BD PAS will notify these customers via mail. BD Contact US Contact Information Customer/Technical Support 888-237-2762 OPT 3, OPT 2; Monday Friday 8:00am - 5:00pm (CT).

    Distribution

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