Recall -- Firm Press Release
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Moog Recalls Curlin Ambulatory Infusion Pump Models 6000 CMS, 6000 CMS IOD, PainSmart, and PainSmart IOD
FOR IMMEDIATE RELEASE - April 8, 2011 - EAST AURORA, NY - Moog Inc. (NYSE: MOG.A) (NYSE: MOG.B) announced today that the Food and Drug Administration (FDA) has classified the voluntary correction of the Curlin 6000 CMS, Curlin 6000 CMS IOD, PainSmart, and PainSmart IOD as a Class I recall. The affected models were manufactured and updated from May 2007 to February 2011. The decision to conduct the device recall is due to a software anomaly which leads to software Error Code 45 (EC45), resulting in a shutdown of the pump. This failure may result in a delay or interruption of therapy, which could result in serious injury and/or death. To date there have been no adverse patient events reported to the Company.
On February 28, 2011, Moog Medical notified all affected customers by Certified Mail and is preparing to take corrective action on the affected products. In the meantime, Moog Medical is providing the following guidance to its customers.
Moog Medical customers who have affected pumps experiencing an Error Code 45 should remove the pumps from service and return the device to Moog.
If you have a pump that exhibits the software error, please contact Moog Medical customer service at 1-800-970-2337, Monday through Friday 7:00 am to 5:00 pm Mountain Standard Time to arrange for the return of all recalled products.
"Moog Medical is committed to the highest level of quality in our products," said Martin Berardi, President of Moog Medical Devices Group. "Our goal is to maximize patient safety and minimize the impact of this field action on our customers." In the first quarter of this year, the Company took a reserve of $1 million to cover the cost of this recall.
Any adverse reactions experienced with the use of this product should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA 5600 Fishers Lane, Rockville, MD 20857, or on the MedWatch web site at:
Moog Inc. is a worldwide designer, manufacturer, and integrator of precision control components and systems. Moog's high-performance systems control military and commercial aircraft, satellites and space vehicles, launch vehicles, missiles, automated industrial machinery, wind energy, marine and medical equipment. Additional information about the company can be found at www.moog.com.