Moog Curlin Infusion, Ambulatory Infusion Pump The Curlin Ambulatory Infusion System includes C...
FDA Recall #Z-0688-2016 — Class II — December 23, 2015
Product 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 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.
Recalling Firm
MOOG Medical Devices Group — Salt Lake City, UT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
11,472
Distribution
Worldwide Distribution - US (nationwide), Guam, and countries of: Australia, Canada, Croatia, Turkey, New Zealand, Saudi Arabia, Japan, Korea, and Italy.
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.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated