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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Dräger Initiates a Voluntary Device Recall of Stabilet Contacts Current Users

Contact:
Glenyce Scott-Hoglund
215-660-2310
Glenyce.scott@draeger.com

FOR IMMEDIATE RELEASE - Telford, PA – July 20, 2009 - Draeger Medical Inc. recommends the removal of Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 from service and replacing them with alternative warmers as soon as it is feasible.

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. Dräger has not been given the opportunity to investigate this incident or to test the Stabilet at issue, and therefore; we cannot comment on ECRI’s investigative conclusions. However, Dräger determined to err on the side of caution and has initiated a voluntary recall. As part of this recall, Dräger agrees with ECRI’s recommendation to remove the Stabilets from service as soon as it is feasible. The recall recommends that the hospital take the following actions:

(1) Hospitals should immediately begin planning to remove the referenced models from service:

  1. Hospitals with sufficient number of unaffected models to meet anticipated clinical needs should immediately remove the referenced warmers from service.
  2. Hospitals currently unable to provide required heating therapy if these units are removed from service should
    1. Begin budgeting for the replacement of the units; and
    2. 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.
    3. 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, Dräger 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 need further information please contact Mike Kelhart (1-800-543-5047 ext 2349). A recall notification is being sent out to all known current users and is available in the Dräger website at www.draeger.com/Stabilet.

 

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