| Class 1 Device Recall Stabliet Infant Warming System |  |
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 | K042607 K850069 K913945 |
Product Classification |
Infant Warming System - Product Code FMT
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = FMT 510(K)s with Product Code = FMT 510(K)s with Product Code = FMT
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