Baxter Healthcare Colleague Volumetric Infusion Pump Baxter Healthcare Syndeo Patient Controlled Analgesic Syringe Pump

Published: Fri Jul 07 00:00:00 -0400 2006

FDA notified healthcare professionals that Baxter Healthcare will stop manufacturing and distributing all models of Colleague Volumetric Infusion Pump and Syndeo Patient Controlled Analgesic Syringe Pump until the company corrects manufacturing deficiencies and is in compliance with FDA's current good manufacturing practice requirements and the Quality System regulation for devices. FDA will allow the firm to continue to provide routine service maintenance, or to replace components, parts, or accessories for the Colleague and Syndeo Infusion Pumps that were already in the hands of customers before October 12, 2005. The Colleague pump has exhibited a variety of problems, including under-infusion, battery failures, false alarms and failure to alarm. FDA issued a Preliminary Public Health Notification on April 28, 2006 with recommendations for users, http://www.fda.gov/cdrh/safety/042806‑baxter.html. Previous MedWatch Alerts: