Gambro warning letter
This article was originally published in The Gray Sheet
Executive Summary
FDA calls for the detention of Prisma and Prismaflex continuous renal replacement therapy systems and Phoenix hemodialysis machines at the U.S. border in a Jan. 5 letter citing quality system concerns, Gambro announced. The agency conducted a non-routine "for-cause" inspection of the Gambro Dasco unit's Medolla, Italy facility in September. The audit did "not directly" respond to an August 2005 Class I Prisma recall relating to the potential for caregivers to inappropriately override one of the system's alarms, Gambro said...