Baxter Expands Pump Infusion Recall

Baxter Healthcare Corp., a medical device supplier, said Tuesday that the company expanded its recall of infusion pumps due to falsified electrical safety data. The company said the update follows the July 25 Class I recall announcement regarding falsified repair, test and inspection data sheets, which included electrical safety data for Colleague and Flo-Gard infusion pumps. The expanded recall includes an additional 986 Colleague infusion pumps, which need to be returned to the company for repeat inspection. After finding falsified service documentation, it is possible that pumps sent to be serviced, repaired or corrected were returned without service being performed on them, the company said in a press release. Previously, the recall was for 534 infusion pump devices serviced in the company’s Phoenix service center. The company said no serious injuries or patient deaths were associated with this recall to date. The Food and Drug Administration classified the issue as a Class I recall on July 24, because of the potential risk of serious injury or patient death if affected devices malfunction. A defect may result in electrical shock, interruption of therapy or other malfunctions, Baxter said. Baxter Healthcare, a subsidiary of Baxter International Inc., assists health care professionals and patients with the treatment of complex medical conditions, including cancer. SOURCE: Boston.com