BEUDAMED
    FDA Recall Terminated

    Greiner bio-one, 4ml K2E EDTA K2 Vacuette tube. Used for venous blood collection. Item number 454209.

    Recall: Z-0184-2012 · Initiated August 12, 2011

    Recall

    Recall Number
    Z-0184-2012
    Event Number
    59919
    Firm
    Greiner Bio-One North America, Inc.
    FEI Number
    3001451379
    Product Code
    JKA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 12, 2011
    Posted
    November 14, 2011
    Terminated
    March 12, 2012
    Address
    4238 Capital Dr, Monroe, NC, 28110

    Description

    Greiner bio-one, 4ml K2E EDTA K2 Vacuette tube. Used for venous blood collection. Item number 454209.

    Reason

    Vacuette 4ml EDTA DK2 tubes have been reported for short fills to no fills.

    Action

    Consignees were notified by Greiner bio-one letter on August 11, 2011. They were instructed to: Stop distributing the material, complete the product Disposition form attach and to fax it to Greiner bio-one and to destroy or return any of the affected products for replacement or credit. Distributors were asked to provide a list of their customers that have received the item, preferably in an Excel file, so that they could be notified of the recall.

    Distribution

    Nationwide.

    Quantity

    504,000 pieces