Baxter Expands Recall of COLLEAGUE and Flo-Gard Infusion Pumps Due to Falsified Repair RecordsAug 8, 2007 | Parker Waichman LLP, LLP
Baxter HealthCare is has added nearly 1,000 devices to its recall of COLLEAGUE and Flo-Gard infusion pumps. Like those in the original recall, these Baxter infusion pumps were sent to the company’s Phoenix service center for repair. It is possible that those repairs were never made and that records were falsified.
In July, Baxter recalled more than 500 infusion pumps after routine quality control inspections revealed that the infusion pumps could have been returned to customers without ever having been repaired. During those inspections, Baxter found that repair, testing and inspection data sheets for the infusion pumps had been falsified. At that time, Baxter said that it had dismissed three employees implicated in the fraud. The Food and Drug Administration (FDA) gave the recall Class I status because the pumps had the potential to cause serious injury and possibly death when used. Now Baxter is recalling an additional 986 infusion pumps for the same reason.
The Baxter infusion pumps are used to administer fluids and medications intravenously. Defects in the pumps could result in over or under infusion. The pumps could also fail to detect air in the intravenous line or occlusions, and they run a risk of causing electrical shock. Other malfunctions could cause infusions of life-preserving fluids and medications to stop.
This is the third recall of Baxter’s infusion pumps this summer. On July 20, the FDA upgraded the company’s recall of 4,500 COLLEAGUE Triple Channel Volumetric Infusion Pumps to Class I status. The infusion pumps had been recalled because of a software glitch that caused the pumps to alarm, display an error code and stop infusion.
Those pumps were replacements for COLLEAGUE pumps Baxter had recalled in February 2005 because they had a tendency to shut down. Prior to the 2005 recall, Baxter had received reports of six injuries and three deaths linked to the malfunctioning infusion pumps. As with all of the other recalls, the FDA also deemed the 2005 action a Class I recall. That recall followed the seizure of 6,000 COLLEAGUE infusion pumps by the FDA.
Baxter has instructed customers with these recalled pumps to contact the company at 1-800-843-7867 to arrange to have their pumps re-serviced. Baxter is also offering to provide customers with loaner pumps while the recalled devices are repaired.
Before it can begin selling any new COLLEAGUE infusion pumps, Baxter must first complete a quality audit process with the FDA. The company has not said when that will be completed, but it does not expect to resume any sales in 2007.