The QMN Weekly Bulletin
Quality / Medical Devices / Postmarket Safety

Hospira Recalls Infusion Pumps, Docking Station for Pumps

June 27, 2014
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Hospira’s troubled infusion operations faced another setback with the announcement last month of two recall actions.

The Lake Forest, Ill.-based company alerted customers May 2 that its GemStar Docking Station, which is used with the GemStar infusion pump, may cause a pump to fail to power up. And when used in conjunction with a battery pack, the pump sometimes detects excess power and issues an alarm. Either error could result in a delay in therapy.

In lieu of returning the docking stations, Hospira suggests turning the pump on and removing the battery pack before plugging it into the docking station.

The products have been in distribution since 2002. In 2013, Hospira announced it was retiring the product line and will cease formally supporting the docking stations on July 31, 2015.

Broken Door Assemblies

Hospira also announced a voluntary Class I recall of Abbott Acclaim infusion pumps and Hospira Acclaim Encore infusion pumps due to customer reports of broken door assemblies. The door helps assure that the tubing is sealed properly to ensure appropriate flow of therapy to the patient. A door that doesn’t close properly could cause an over-infusion or delay of therapy, the company said.

The affected pumps were manufactured and distributed between February 1997 and November 2013. The company is asking customers to inspect all pumps in use for door cracks and retire from service any that are found to be defective.

Hospira has faced a slew of regulatory problems in recent years.

In April, the company withdrew an anesthetic after steel particles were detected in the solution. And in March, the company’s Rocky Mount, N.C., plant received a warning letter complaining that its corrective and preventive action procedures for devices fall short of expectations — the second warning letter the plant had received since 2010.

The company did not respond to a request for comment on the latest quality issues.

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