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U.S. Department of Health and Human Services

Class 2 Device Recall Curlin Ambulatory Volumetric Infusion Pump

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 Class 2 Device Recall Curlin Ambulatory Volumetric Infusion Pumpsee related information
Date Initiated by FirmDecember 23, 2015
Date PostedFebruary 11, 2016
Recall Status1 Terminated 3 on February 21, 2017
Recall NumberZ-0688-2016
Recall Event ID 72923
510(K)NumberK981816 
Product Classification Pump, infusion - Product Code FRN
ProductMoog 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.
Code Information All manufactured or serviced by MMDG between March 18, 2015 and November 6, 2015. Curlin 4000, catalog number 340; Curlin 6000, 6000 CMS, and PainSmart IOD, catalog number 360; and Curlin Pump Calibration Set, catalog number 340-4038.
FEI Number 1000117172
Recalling Firm/
Manufacturer		 MOOG Medical Devices Group
4314 S Zevex Park Ln
Salt Lake City UT 84123-7881
For Additional Information ContactRobert Reese
801-264-1001 Ext. 114
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionMoog 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: MoogMedicalSupport@moog.com 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: cdodge@moog.com Monday through Friday, 8:00 AM to 5:00 PM, Mountain Time.
Quantity in Commerce11,472
DistributionWorldwide Distribution - US (nationwide), Guam, and countries of: Australia, Canada, Croatia, Turkey, New Zealand, Saudi Arabia, Japan, Korea, and Italy.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FRN
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