Moog Curlin Ambulatory Infusion Pump Recall Deemed Class I

Moog Inc. of East Aurora, New York just announced that the U.S. Food and Drug Administration (FDA) has classified its medical device recall of the <"">Curlin 6000 CMS, Curlin 6000 CMS IOD, PainSmart, and PainSmart IOD ambulatory infusion pumps, as a Class I recall.

A Class I recall is the agency’s most serious and indicates that the recall refers to a situation in which there is a reasonable probability that the use of or exposure to the recalled product will cause serious adverse health consequences or death.

The recalled Curlin Ambulatory Infusion Pumps were manufactured and updated from May 2007 to February 2011. The decision to conduct the device recall was because of a software anomaly that leads to software Error Code 45 (EC45). This error causes the pump to shutdown.

This medical device failure may result in a delay or interruption of therapy, which could result in serious injury and/or death. To date, no adverse patient events have reported to Moog Inc.

On February 28, 2011, Moog Medical notified all affected customers of the recall by Certified Mail and said it is preparing to take corrective action. Meanwhile, Moog Medical is advising its customers who have the affected, recalled pumps and who are experiencing an Error Code 45, to remove the pumps from service and return the device to Moog.

Moog Medical customer service can be reached, toll-free, at 1.800.970.2337, Monday through Friday, from 7:00 a.m. to 5:00 p.m., Mountain Standard Time, to arrange for the return of all recalled products.

Adverse reactions experienced with the use of this product should be reported to the FDA’s MedWatch Program by phone, toll-free, at 1.800.FDA.1088; by fax at 1.800.FDA.0178; by mail at MedWatch, FDA 5600 Fishers Lane, Rockville, Maryland 20857; or on the MedWatch web site.

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