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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 Device Recall Stabliet Infant Warming Systemsee related information
Date Initiated by FirmJuly 17, 2009
Date PostedAugust 25, 2009
Recall Status1 Terminated 3 on June 01, 2011
Recall NumberZ-1955-2009
Recall Event ID 52718
510(K)NumberK042607 K850069 K913945 
Product Classification Infant Warming System - Product Code FMT
ProductStabilet 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 PA 18969-1042
For Additional Information ContactMicheal 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
Equipment maintenance
ActionOn 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 Commerce6489 units
DistributionWorldwide 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 CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FMT
510(K)s with Product Code = FMT
510(K)s with Product Code = FMT
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