Image via CrunchBaseThe FDA has issued specific instructions to Baxter Healthcare for how to handle the recall of thousands of Colleague Volumetric Infusion Pumps.
The orders require Baxter to ship replacements or issue refunds for affected products and continue to provide batteries, spare parts, and service for devices held by customers with certificates of medical necessity.
Additionally, Baxter must maintain service of pumps held by customers with the certificate for 24 months following today's order or until the customer has made use of a replacement product.
The recall was issued in early May, when the FDA required Baxter to recall and destroy the fluid delivery pumps. The announcement came after the agency said in April it received 56,000 adverse event reports -- including 500 deaths -- related to infusion pump use from all manufacturers from 2005 to 2009.