FDA slaps Hospira with Class I recall over infusion pump problems

Hospira ($HSP) now faces a Class I recall--the FDA's most serious--because of malfunctioning problems with the company's Symbiq infusion pump system.

The designation affects the company's Symbiq One and Two infusion pump models; both are used to deliver intravenous medication to patients. What's at issue here is the touch screen for both models, which controls patients' medication settings. Hospira issued a "correction letter" back in August because the touch screen, in some cases, wouldn't respond to user instructions, offered a delayed response or registered a different setting than what the user selected. The letter, rather than instructing customers to return the affected pumps, offered instructions to confirm correct infusion settings and how to stop an infusion if problems arise.

Hospira's problems appear to come down to a software glitch. FDA officials, in their recall, note that the company is designing a patch to fix it and will notify customers accordingly.

Hospira has had a rough year with manufacturing-related recalls. Earlier this month the company said it was recalling a lot of injectable dextrose after finding mold in a leaky container. And the FDA is already warning Hospira for separate infusion pump manufacturing problems at a Costa Rica plant, among other issues.

- here's the FDA's recall statement

Suggested Articles

Takeda tapped Roche’s Foundation Medicine to develop tissue- and blood-based companion diagnostic tests for its portfolio of lung cancer therapies.

Cellex has announced plans to develop a rapid coronavirus test that people can fully perform at home, from sample collection to result, using an app.

More than 20 states either don’t release or have incomplete data on the rapid antigen tests now considered key to containing the coronavirus.