BEUDAMED
    FDA Recall Terminated

    Clark Biocompatible Hemoperfusion Cartridge, sorbent: Heparinized polymer over acitivated carbon, 250mL, Clark Research and Development, Inc. Folsom, LA 70437

    Recall: Z-0553-2007 · Initiated January 19, 2007

    Recall

    Recall Number
    Z-0553-2007
    Event Number
    37289
    Firm
    Clark Research and Development Inc Number
    FEI Number
    2316506
    Product Code
    FLD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 19, 2007
    Posted
    February 28, 2007
    Terminated
    July 17, 2007
    Address
    13 Park Lane, Folsom, LA, 70437

    Description

    Clark Biocompatible Hemoperfusion Cartridge, sorbent: Heparinized polymer over acitivated carbon, 250mL, Clark Research and Development, Inc. Folsom, LA 70437

    Reason

    Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions

    Action

    The firm notified its consignees of the problem and the recall via letter (priority mail with delivery confirmation)dated 01/19/2007 beginning on 01/19/2007. This letter requested that the consignee cease the use of this product and contact the recalling firm for return instructions. Follow-up with non-reponders will be made by facsimile.

    Distribution

    Nationwide

    Quantity

    276