Dräeger/Hill-Rom Stabilet Infant Warmer Recall
Infant Warmer Recall:
In July 2009 Draeger Medical and FDA notified healthcare professionals of a class 1 recall and recommended the removal of Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 from service as soon as possible due to concern that continued use of these devices may result in serious injury to the patient and/or caregiver. A January 2008 fire in a Minnesota neonatal unit injured an infant and an independent investigation concluded that the Hill-Rom Stabilet 1250 was likely the ignition source of the fire. Dräeger agrees with the recommendation to remove the referenced Stabilet models from service immediately.
Stabilet Infant Warmers Being Recalled:
Stabilet Infant Warmer, model numbers 200, 300, 1250, 1500, 200/3000, 2000,
2200/3200, 3000, and 3200.These devices were manufactured from January 1, 1987
through December 31, 1998 and were distributed from December 1, 1987 through
November 30, 1999.
Additional Information:
On July 20, 2009, Dräeger sent a recall letter to all known customers, requested customers remove the affected devices from service, remove the heating element and the power cord to make the device unusable once removed from service and emphasized these devices are not to be used, donated or sold for any other purpose. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.
Infant Warmer Recall News Archive>>>
Read FDA Recall Notice>>>
The recall recommends that the hospital take the following actions:
(1) Hospitals should immediately begin planning to remove the referenced models from service:
*Hospitals with sufficient number of unaffected models to meet anticipated clinical needs should immediately remove the referenced warmers from service.
*Hospitals currently unable to provide required heating therapy if these units are removed from service should:
*Begin budgeting for the replacement of the units; and
*Limit use of the referenced models to patients NOT requiring O2 – enrichment may increase the risk of fire. Hospitals should inform all potential users of this restriction and clearly mark referenced units to reinforce this message.
*Use a different heating modality (e.g., an infant incubator) if an infant requires O2therapy (whether supplemental or via intubation) and no unaffected warmers are available.
(2) 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.
In 2004, Dräeger 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 Dräger. 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.
If you or your infant has suffered injury or loss due to a defective Stabilet infant warmer you may be entitled to compensation. Contact theStabilet infant warmer lawyers of Ennis & Ennis, P.A. today by filling out the Case Evaluation Form on this page or call toll-free: 1-800-856-6405. Nationwide Free Legal Consultations.
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