Saturday, July 25, 2009

Recall Issued for All Stabilet Infant Warmers

Neil Osterweil

Authors and Disclosures

Published: 07/23/2009

July 23, 2009 — Medical device maker Draeger Medical Inc, working with the US Food and Drug Administration (FDA), has issued a recall of all Stabilet Infant Warmer models because of the potential for serious injury to patients and/or caregivers from their continued use.

The FDA and Draeger recommend that the devices be immediately removed from service and replaced as soon as possible.

In January 2008, a fire injured an infant in a Minnesota neonatal unit; it has since been determined by independent investigators that the Hill-Rom Stabilet model 1250 was the likely ignition source.

However, all models are involved in the recall, said Draeger spokeswoman Glenyce Scott-Hoglund in an interview with Medscape Medical News. The model numbers are 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200. About 6200 total infant warmer units were manufactured by Hill-Rom from the mid-1980s through 1998. Service and support for the units was discontinued in 2003. Draeger acquired Hill-Rom in 2004.

According to an alert from MedWatch, the FDA's safety information and adverse event reporting program, "immediate actions required include:

Locate and identify the devices listed in this notice.
Remove the referenced devices from service as soon as possible.
Once removed from service, the warmers should be rendered unusable by removing the heating element and the power cord. These warmers should not be used or sold for any other purpose.
If an infant is currently receiving therapy from one of the referenced devices, consider the risk of moving the patient before changing to an alternative mode of therapy."
Draeger has issued a recall notification to all known users of the affected models.

More information is available on the MedWatch Web site.

Authors and Disclosures
Neil Osterweil
Neil Osterweil is a freelance writer for Medscape.

No comments: