MOOG Medical Devices Group recalls Moog Curlin Infusion, Ambulatory Infusion Pump The Curlin Ambulatory Infusion System includes Curlin Ambulatory multi-t…

Recall date

December 23, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0688-2016

FDA classification

Class II

Brand / firm

MOOG Medical Devices Group

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.