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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 System see related information
Date Initiated by Firm July 17, 2009
Date Posted August 25, 2009
Recall Status1 Terminated 3 on June 01, 2011
Recall Number Z-1955-2009
Recall Event ID 52718
510(K)Number K850069  K913945  K042607  
Product Classification Infant Warming System - 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 PA 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		 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 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) 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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