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.
FDA Recall Z-0688-2016 · Posted 2016-02-11
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Recalling FirmMOOG Medical Devices Group
Recall StatusTerminated
Product CodeFRN
Date Initiated2015-12-23
Date Terminated2017-02-21
Product Quantity11,472
Reason for Recall
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - US (nationwide), Guam, and countries of: Australia, Canada, Croatia, Turkey, New Zealand, Saudi Arabia, Japan, Korea, and Italy.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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