Moog Curlin Infusion, Ambulatory Infusion Pump The Curlin Ambulatory Infusion System includes Curlin Ambulatory multi-th

FDA device recall Z-0688-2016 · posted 2016-02-11 · Terminated

Recall details

Recalling firm

MOOG Medical Devices Group

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.

Action taken

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: 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.

Root cause

Process control

Status

Terminated

Product code

FRN

Quantity affected

11,472

Distribution

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

Date initiated

2015-12-23

Date posted

2016-02-11

Date terminated

2017-02-21

Location

Salt Lake City, UT

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