Drager Initiates a Voluntary Device Recall of Stabilet Infant Warmer

Drager Medical Inc., has initiated a voluntary recall of Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200.

This action is in response to an event that took place in a neonatal unit of a hospital in Minnesota in 2008. ECRI conducted an investigation of the event and concluded that the likely cause was the Stabilet.

In 2004, Drager acquired from Hill-Rom Co., Inc. (the manufacturer of this product) the Stabilet product line of radiant infant warmers. Hill-Rom discontinued manufacturing the Stabilet product line in 1998, six years prior to its sale to Drager. Service support and spare parts for Stabilets were discontinued at the end of 2003. All known users of this product line were informed that this product was discontinued at this time.

JULY-20-09: Drager Initiates a Voluntary Device Recall of Stabilet [FDA: DRAGER STABILET RECALLED]

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Published on Jul-20-09