Company: Moog, Inc.
Date of Enforcement Report 4/8/2011
Class l:
Moog Incannounced 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.
