Hospira Recalls Gemstar Infusion System

Illinois-based Hospira has been hit with yet another recall, this time of its GemStar infusion system. The current Class I recall was initiated March 15 via an “Urgent Device Field Correction” letter sent to customers that purchased the device directly from Hospira.

The recall applies to models 13000, 13100, 13150, 13086, 13087 and 13088. Systems manufactured, or whose pressure sensor was replaced, since Jan. 1, 2009, may also be affected.

According to the letter, the proximal and distal pressure sensor calibration on the device can drift, causing it not to pick up on occlusions or to issue false occlusions alarms. Over-infusion or a delay or interruption in infusion can result in serious injury or death. Neither has been reported, the letter notes.

Hospira said it has notified the FDA of the recall and is adding recommendations for annual proximal and distal occlusion tests. The company recommends that users whose devices were not recalled also perform these tests yearly.

GemStar has been available in the U.S. since 1999.

Read the letter at www.fdanews.com/ext/resources/files/11/11-27-13-HospiraRecall.pdf. — Lena Freund

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