FDA Issues To Class I Recall To Baxter's Spectrum Infusion Pump

In December 2021, Baxter International Inc BAX issued an urgent safety communication about an issue with some of its Spectrum infusion pumps. The FDA has identified this as a Class I recall, the most serious type of recall.

The recall pertains to Baxter's Spectrum V8 and Spectrum IQ infusion pumps used in clinical settings to deliver controlled amounts of fluids such as pharmaceutical drugs, blood & blood products, and other required patient therapies.

Baxter identified a technical issue with the devices that may keep them from emitting an alarm for repeated upstream occlusions as detailed in the original safety notice. The system becomes blocked between the IV bag and the pump. The use of the affected products may cause serious adverse events, including death. 

Related: Baxter Recalls Dose IQ Software 9.0.x Used With Infusion Pumps.

According to the FDA, the recall encompasses over 277,000 devices distributed in the U.S. between early 2015 and this year.

Baxter received 51 reports of serious injuries and three reports of patient deaths over five years, potentially associated with this issue. 

Despite the recall, healthcare providers can still safely use the affected pumps if they follow all on-screen and safety manual instructions, Baxter added. 

Baxter is not requesting that devices be returned to the company nor replaced.

Price Action: BAX shares are up 1.71% at $78.17 during the market session on the last check Monday.