Baxter, Covidien Recall Devices

The U.S. Food and Administration (FDA) has given Baxter International Inc.’s Colleague infusion pump the most serious recall designation after it demonstrated a variety of problems including battery failures, trouble with false alarms and inadequate infusion.

The Deerfield, Ill.-based pharmaceutical and healthcare product manufacturer has not sold the pump in the United States since 2005.

In January, Baxter sent customers a letter warning them that certain models of the Colleague Volumetric Infusion Pumps have a failure code problem. The infusion-pump devices are designed to monitor a variety of sensors, electronics and medical control software during patient therapy, and to automatically shut down and sound an alarm if an unexpected or potentially dangerous situation arises. But Baxter’s letter said that failure codes and subsequent unwanted shutdowns could be triggered by certain sequences of inputs by operators or other factors.

“There have been serious injuries and/or deaths associated with failures identified in this letter,” Baxter warned in its note.

The notification of problems with Baxter’s infusion pump is considered by the FDA a Class 1 recall, “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

The Baxter recall came just days after a Class I recall of Covidien Ltd.’s pediatric tracheostomy tubes. That recall was prompted by complaints of difficulties inserting the product into patients, according to the FDA.

The FDA said Monday that Covidien Ltd started recalling 21 lots of the Shiley 3.0PED Cuffless Pediatric Tracheostomy Tube in January. The device, manufactured July 7, 2008 to Dec. 9, 2008, are used during surgery to create an opening through the neck into a child’s trachea.