Stabilet Infant Warming System, model numbers 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200.
- Company
- Draeger Medical Systems, Inc.
- Recall Initiated
- July 17, 2009
- Posted
- August 25, 2009
- Terminated
- June 1, 2011
- Recall Number
- Z-1955-2009
- Quantity
- 6489 units
- Firm Location
- Telford, PA
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.
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.
Lot / Code Info
All units of model numbers 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200.
Root Cause
Equipment maintenance
Action Taken
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.