BEUDAMED
    FDA Recall Terminated

    ***This recall is being conducted due to an incomplete recall for RES 57829*** Curlin Infusion Administration Set, REF 340-4165, Sterile EO, The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.

    Recall: Z-0072-2013 · Initiated September 26, 2012

    Recall

    Recall Number
    Z-0072-2013
    Event Number
    63359
    Firm
    MOOG Medical Devices Group
    FEI Number
    1000117172
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 26, 2012
    Posted
    October 17, 2012
    Terminated
    April 5, 2013
    Address
    4314 Zevex Park Ln, Salt Lake City, UT, 84123-7881

    Description

    ***This recall is being conducted due to an incomplete recall for RES 57829*** Curlin Infusion Administration Set, REF 340-4165, Sterile EO, The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.

    Reason

    This recall is the same issue for the FDA processed recall initiated by Moog Medical Devices on 1/25/11 which was related to customers reporting unclearable Air-In-Line alarm with specific lot numbers of Curlin Administration Sets used with Curlin Ambulatory Infusion Pumps. The lots associated with this recall were inadvertently omitted from the original recall which has since been terminated by

    Action

    MOOG sent a Medical Device Recall Notification letter dated September 26, 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove product from their inventory and return to the firm. Customers were also instructed to contact their distributor to arrange for replacement product. For questions customers were instructed to call 1-800-970-2337, prompt #7. For questions regarding this recall call 801-264-1001.

    Distribution

    Nationwide Distribution including California

    Quantity

    12,000 sets