DEERFIELD, Ill. (AP) -- The Food and Drug Administration gave a safety hazard warning letter issued by Baxter International Inc. over its Colleague Volumetric Infusion pumps, its most severe level of urgency, the company said Wednesday.
In January, Baxter issued a warning to customers over potential hazards with the products, which includes failure to pump and overheating. The FDA classified the company's letter as a Class I recall, its most severe warning.
The products, which are used widely in hospitals to deliver intravenous fluids and medicine to patients, are not actually being called off the market, but the serious warning is necessary because the products are so widely used and the shutdown hazard could be potentially fatal.
The company said failure codes in the pumps could cause them to shut down while delivering fluids to patients and warned of overheating. It said safe and effective use of the product depends on proper battery care practices.
Affected model numbers include all Colleague Volumetric Infusion Pump Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE 2M9161 and 2M9163. Customers with questions regarding this notice may contact Baxter at 1-800-THE-PUMP (1-800-843-7867), between 7 a.m. and 5 p.m. CDT.
Shares of the company fell $2.27, or 4.4 percent, to $49.07 in afternoon trading.