The FDA has required Baxter Healthcare to take specific steps to carry out the April recall of all colleague volumetric infusion pumps (CVIP) and to provide customers with a refund, a replacement pump or lease termination.
The Deerfield, Ill.-based company is responsible for recalling as many as 200,000 CVIP currently in use in the U.S. Under the FDA’s requirements, Baxter also will provide a transition guide to assist customers affected by the recall. The guide will include a list of FDA-cleared or approved pump alternatives, suggestions to help minimize disruption and patient risk during the transition period, and detailed information on the refund, replacement and lease termination programs.
“FDA is requiring Baxter to provide replacements or refunds for these recalled devices,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health.
According to the FDA, Baxter will continue to provide batteries, spare parts and service for the affected pumps during the transition period for customers who submit a Certificate of Medical Necessity to Baxter. The certificate, provided by Baxter, asks for information such as the number of CVIP currently in use, serial numbers and the anticipated date that the CVIP will be removed from use. After receiving the completed certificate, the FDA said that Baxter will continue service for 24 months after today’s date, or until the customer has transitioned to another pump.
Baxter will complete the recall and the replace or refund programs by July 14, the agency said.
The FDA said it has been working with Baxter since 1999 to correct numerous flaws in the CVIP, that have been the subject of several Class I recalls for battery failures, inadvertent powering off, service data errors and other issues. On April 8, Baxter submitted a proposed correction schedule for the CVIP that the FDA found unacceptable. The FDA ordered the recall and replace or refund action pursuant to the authority granted to the agency by the 2006 consent decree.