BEUDAMED
    FDA Recall Terminated

    Moog Curlin Infusion, Ambulatory Infusion Pump The Curlin Ambulatory Infusion System includes Curlin Ambulatory multi-therapy and PainSmart pumps. Curlin 4000, catalog number 340; Curlin 6000, 6000 CMS, and PainSmart IOD, catalog number 360; and Curlin Pump Calibration Set, catalog number 340-4038.

    Recall: Z-0688-2016 · Initiated December 23, 2015

    Recall

    Recall Number
    Z-0688-2016
    Event Number
    72923
    Firm
    MOOG Medical Devices Group
    FEI Number
    1000117172
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 23, 2015
    Posted
    February 11, 2016
    Terminated
    February 21, 2017
    Address
    4314 S Zevex Park Ln, Salt Lake City, UT, 84123-7881

    Description

    Moog Curlin Infusion, Ambulatory Infusion Pump The Curlin Ambulatory Infusion System includes Curlin Ambulatory multi-therapy and PainSmart pumps. Curlin 4000, catalog number 340; Curlin 6000, 6000 CMS, and PainSmart IOD, catalog number 360; and Curlin Pump Calibration Set, catalog number 340-4038.

    Reason

    Moog is recalling Curlin 4000, 6000, and PainSmart Infusion Pumps manufactured or serviced by MMDG between March 18, 2015 and November 6, 2015 because the master pumps used to calibrate them were out of tolerance and may cause an over delivery of medications and solutions at a rate of 1.2 - 6.8% faster than programmed.

    Action

    Moog Medical Device Group sent an "Urgent Recall Notice" dated December 22, 2015, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove all of their current Calibration Sets from service before placing these new sets into service. Customers were also instructed to complete and return the Recall Reply Form by fax: 801-264-1051 or email to: [email protected] and for any questions, please contact: Moog Regulatory Affairs at 801-264-1001. For additional information or clarification call 801-264-1001, ext. 112 or via email at: [email protected] Monday through Friday, 8:00 AM to 5:00 PM, Mountain Time.

    Distribution

    Worldwide Distribution - US (nationwide), Guam, and countries of: Australia, Canada, Croatia, Turkey, New Zealand, Saudi Arabia, Japan, Korea, and Italy.

    Quantity

    11,472