BEUDAMED
    FDA Recall Terminated

    Celsus Laboratories Heparin Lithium Lyophilized; Lithium Heparin for use in blood collection tube devices and in vitro diagnostic devices.

    Recall: Z-1917-2008 · Initiated March 31, 2008

    Recall

    Recall Number
    Z-1917-2008
    Event Number
    48084
    Firm
    Celsus Laboratories Inc
    FEI Number
    1527761
    Product Code
    JKA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 31, 2008
    Posted
    July 18, 2008
    Terminated
    September 21, 2012
    Address
    12150 Best Pl, Cincinnati, OH, 45241-1569

    Description

    Celsus Laboratories Heparin Lithium Lyophilized; Lithium Heparin for use in blood collection tube devices and in vitro diagnostic devices.

    Reason

    Contamination: The firm learned that up to 2.2% oversulfated chondroitin was found in a batch of crude heparin they received from their supplier.

    Action

    Celsus notified their customers by e-mail on April 24, 2008, explaining that oversulfated chondroitin was found in a batch of crude heparin they received from their supplier. Celsus recommended the device manufacturers quarantine material from the specified lots.

    Distribution

    Worldwide Distribution. The Lithium Heparin was sold to companies in USA (Nebraska, New Jersey, Ohio), Puerto Rico, Austria, and Denmark.

    Quantity

    HL-31707=11,542g, HL-31807=12,836g, HL-32708=8,374g, HL-32808=12,128g & HL-32908=5,000g