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Hospira's FDA Woes Will Soon Be Pfizer's Problem

The problem this time involves nearly 4700 infusion pumps that may have faulty alarms.

Chris Newmarker

Hospira Plum A+ Infusion System
The Hospira Plum A+ infusion pump, as shown on the company's website.

FDA recently posted a Class I designation for a Hospira recall involving nearly 4700 Plum A+ and A+3 infusion pumps. 

The latest Hospira recall comes as the Lake Forest, IL-based company is in the process of being acquired by pharmaceutical giant Pfizer in a $17 billion deal.

The recall involves alarms that might not sound when a therapy is interrupted. Regulators think such a situation could cause serious injury or death because it could result in long delays before health professionals realize there is a problem.

Hospira has contracted with Stericycle in Indianapolis for notification, according to FDA. Stericycle sent two Urgent Medical Device Correction letters dated July 2, 2014 and July 16, 2014, instructing customers how to test the alarm. Hospira is replacing any infusion pumps that fail the alarm test.

More information is available with FDA announcement, which FDA posted online Thursday.

This is the ninth time since the start of 2012 that Hospira has faced a Class I-level recall.  Five of the recalls involved another infusion pump, the GemStar Infusion System. The GemStar, in some ways, is a telling example of how a medical device can fail in multiple ways. 

Refresh your medical device industry knowledge at BIOMEDevice Boston, May 6-7, 2015.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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