May 1 Baxter Healthcare Corp is recalling some models of its infusion pumps used to deliver medicine, blood and other fluids after it received over 3,500 reports of malfunctioning, the U.S. Food and Drug Administration said.
The reports included nine severe adverse events, but no deaths, the regulator said on Thursday. (link.reuters.com/suf98v)
The recalled devices, Sigma Spectrum infusion pumps with master drug library model no. 35700BAX and 35700ABB, were reported to improperly detect that the pump's door was open, leading to an interruption or delay in therapy.
The affected products were made between July 1, 2005 and Jan. 15 and distributed between Feb. 20, 2013 and Jan. 15.
The recall was classified as the most serious Class 1 type, where there is a probability that use of the product will cause serious health problems or death.
The Deerfield, Illinois-based company's shares were up about 2 percent at $74 on the New York Stock Exchange. (Reporting by Natalie Grover in Bangalore; Editing by Don Sebastian)