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U.S. Department of Health and Human Services

Class 1 Device Recall Stabliet Infant Warming System

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 Class 1 Recall
Stabliet Infant Warming System
see related information
Date Posted August 25, 2009
Recall Status1 Open
Recall Number Z-1955-2009
Recall Event ID 52718
Premarket Notification
510(K) Numbers
K042607  K850069  K913945 
Product Classification Warmer, Infant Radiant - Product Code FMT
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
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Equipment Maintenance
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FMT and Original Applicant = BORNING CORP.
510(K)s with Product Code = FMT and Original Applicant = DRAEGER MEDICAL, INC.
510(K)s with Product Code = FMT and Original Applicant = HILL-ROM, INC.
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