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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 1 Recall
Stabliet Infant Warming System		see related information
Date Posted August 25, 2009
Recall Number Z-1955-2009
Product Stabilet Infant Warming System, model numbers 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200.
Code Information All units of model numbers 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200.
Recalling Firm/
Manufacturer		 Draeger Medical Systems, Inc.
3135 Quarry Rd
Telford, Pennsylvania 18969-1042
For Additional Information Contact Micheal Kelhart
800-543-5047
Reason for
Recall		 Hot particles fell into the infant bassinet beneath a Radiant Infant Warmer. The resulting fire injured an infant. These devices are obsolete.
Action On 7/20/09, Draeger Medical, the recalling firm, issued a press release to medical media outreach organizations and an Urgent Medical Device letter to all known customers. This information explained the incident and the need to remove and replace the units in question as soon as feasibly possible.
Quantity in Commerce 6489 units
Distribution Worldwide distribution: USA, Brazil, Canada, China, Dominican Republic, France, Korea, Lebanon, Mexico, Nigeria, Panama, Poland, Saudi Arabia, Taiwan, Turkey, United Kingdom, Uruguay, and Venezuela.
 
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