BEUDAMED
    FDA Recall Terminated

    LH Lithium Heparin tubes, Greiner bio-one, North America, 4238 Capital Drive, Monroe, NC 28110. Venous blood collection tubes.

    Recall: Z-1081-2012 · Initiated December 14, 2011

    Recall

    Recall Number
    Z-1081-2012
    Event Number
    60748
    Firm
    Greiner Bio-One North America, Inc.
    FEI Number
    3001451379
    Product Code
    JKA
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    December 14, 2011
    Posted
    February 22, 2012
    Terminated
    June 21, 2012
    Address
    4238 Capital Dr, Monroe, NC, 28110

    Description

    LH Lithium Heparin tubes, Greiner bio-one, North America, 4238 Capital Drive, Monroe, NC 28110. Venous blood collection tubes.

    Reason

    The lithium heparin tubes may have a contamination with EDTA potassium.

    Action

    Greiner Bio-One sent a "RECALL OF LITHIUM HEPARIN TUBES WITH EDTA CONTAMINATION" letter dated December 13, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to complete an attached Product Disposition Site Confirmation Form and to fax the form to 800-726-0052. This form will confirm that customers have discarded/destroyed all affected product. The firm will replace the product after receipt of the form. Contact the firm at 800-515-8112 for questions regarding this recall.

    Distribution

    Nationwide Distribution.

    Quantity

    2,082,000 pieces