Regulatory Focus™ > News Articles > Infusion Pump Maker Warned About Alarm Problems

Infusion Pump Maker Warned About Alarm Problems

Posted 30 August 2012 | By

The U.S. Food and Drug Administration (FDA) issued a warning letter to Hospira, Inc., about problems with alarm systems in its infusion pumps, according to a Reuters report.

Hospira said the letter does not restrict production or shipping of the pump from its plant in Costa Rica. A spokeswoman for the company said it was changing components in the pump and expected to be done by early 2013.

FDA's letter said the agency received complaints about the Plum brand infusion pump alarm even after the part was redesigned. The pump had been recalled in February 2011 because of alarm problems.

Read more

Regulatory Focus newsletters

All the biggest regulatory news and happenings.