Baxter Expands Class I Recall of Drug Infusion Pumps

Baxter Healthcare announced it is expanding its July 25 Class I recall to include an additional 986 Colleague infusion pumps, which need to be returned to the company for repeat inspection because of “falsified electrical safety data.”

The original recall was due to falsified repair, test and inspection data sheets for the Colleague and Flo-Gard infusion pumps, the company said (Device Daily Bulletin, July 31). It is possible that pumps sent to be serviced, repaired or corrected were returned without service being performed on them, it said. Baxter dismissed three employees from its Phoenix, Arizona, service center in connection with the recall.

Previously, the recall pertained to 534 infusion pump devices serviced in the Phoenix service center. The expansion of the recall represents pumps serviced by all three employees who were dismissed, Baxter said, adding that its investigation of the matter is continuing. 
 
The company added there are no serious injuries or patient deaths associated with the recall to date. The recall only affects pumps distributed in the U.S.