BEUDAMED
    FDA Recall Terminated

    2.0 mL Cartridge/Syringe Piston component of Insulin Pump Insulin infusion

    Recall: Z-1678-2011 · Initiated February 25, 2011

    Recall

    Recall Number
    Z-1678-2011
    Event Number
    58047
    Firm
    Animas Corporation
    FEI Number
    3002920072
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    February 25, 2011
    Posted
    May 10, 2011
    Terminated
    April 3, 2014
    Address
    200 Lawrence Dr, West Chester, PA, 19380-3428

    Description

    2.0 mL Cartridge/Syringe Piston component of Insulin Pump Insulin infusion

    Reason

    Action is being undertaken to address the occurrence of adverse events associated with leaking cartridges. Firm became aware of this issue through customer complaints from pump users reporting the cartridges were leaking.

    Action

    Animas Corporation sent an Urgent Recall letter dated February 22, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Change their cartridge immediately using the instructions provided. Return all of the unused affected product using the enclosed box. Shipments must be returned using the United States Postal Service. For technical questions call Animas Customer Support at 1-855-254-5668 or call the toll free number at 1-8777-937-7867. For any questions about returning the product call 1-877-280-2339. Customers were instructed to notify the firm by logging on to the following website: www.animasnotification.com or call the Call Center at 1-877-280-2339 if they have no product to return.

    Distribution

    Worldwide Distribution - USA (nationwide) and France.

    Quantity

    384,180