BEUDAMED
    FDA Recall Terminated

    VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged

    Recall: Z-2485-2021 · Initiated August 13, 2021

    Recall

    Recall Number
    Z-2485-2021
    Event Number
    88511
    Firm
    Greiner Bio-One North America, Inc.
    FEI Number
    3001451379
    Product Code
    JKA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 13, 2021
    Terminated
    August 16, 2023
    Address
    4238 Capital Dr, Monroe, NC, 28110-7681

    Description

    VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged

    Reason

    Blood collection tubes may experience a clotting issue.

    Action

    A distributor and customer letter dated 08/12/2021 was issued to affected consignees. Customers are advised to stop using the recalled product immediately and quarantine affected product within the facility. Customers are asked to complete a Product Disposition form and return to the recalling firm. The firm issued additional letters dated 9/10/2021 on 9/13/2021 via email to distributors and via USPS to other customers informing them of an additional lot number of product that is affected. The letters provide similar instructions as the initial letter.

    Distribution

    Distribution was made to AL, AZ, CO, CT, FL, IL, MA, MD, MI, MO, NC, NM, PA, TX, and VA. Foreign distribution was made to Canada.

    Quantity

    962,400 tubes