Baxter Healthcare 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. Pumps sent to be serviced, repaired, or corrected may have been returned without service being performed on them. Baxter dismissed three employees from its Phoenix 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 and the company’s investigation of the matter is continuing.
Baxter added there are no serious injuries or patient deaths associated with the recall to date. The recall only affects pumps distributed in the United States.
Contact Baxter online or at (800) 843-7867 and arrange for repeat inspection and servicing or for loaner devices, free of charge. Representatives are available Monday through Friday from 7 am to 5 pm CDT.