Moog Recalls Curlin Ambulatory Infusion Pump Models 6000 CMS, 6000 CMS IOD, PainSmart, and PainSmart IOD
Mon, 11 Apr 2011 14:10:00 -0500
EAST AURORA, NY--(Marketwire - April 08, 2011) - 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.
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U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420
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