The U.S. Food & Drug Administration (FDA) has issued a Class 1 recall for Baxter Healthcare's Colleague brand volumetric infusion pumps. A Class 1 recall is the harshest warning available meaning that continued use of the products could lead to serious injury or death.

Reasons for the recall

The FDA instituted the recall after the Deerfield Illinois based medical device maker reported that it had identified software and battery usage failures that could result in a delay in or interruption of infusion that may cause serious injury and/or death. The company has alerted customers to several safety problems with its Colleague infusion pumps.

The letter provides consumers with steps for addressing the safety situations. Baxter advises institutions to have contingency plans and to verify that back-up pumps are available in case life-sustaining therapies are disrupted. It also states that it has received a higher than expected number of "damaged battery" messages which can be corrected by taking the pump out of service and installing new batteries with a battery harness. To view the letter, click here.

Products affected by the recall

The products affected by the recall include all COLLEAGUE Volumetric Infusion Pump Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE 2M9161 and 2M9163. According to Baxter, the Colleague Volumetric Infusion Pump is “a medical device that delivers intravenous fluids and medicine to patients in hospitals, outpatient surgical centers, hospices, nursing homes, and in ambulances. It is used throughout the hospital, including in the emergency room, the I.C.U. [intensive care unit] labor and delivery, and in pediatric units.”

Need additional information?

Customers with questions related to the COLLEAGUE pump are advised to call 1-800-THE-PUMP. Injured victims should contact an experienced products liability attorney to discuss their situation and evaluate their options.