Moog Recalls Curlin Ambulatory Infusion Pump

East Aurora, NY: Moog Inc has announced 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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Published on Apr-12-11