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Terminated

Stabilet Infant Warming System, model numbers 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200.

FDA Recall Z-1955-2009 · Posted 2009-08-25

Recalling FirmDraeger Medical Systems, Inc.
Recall StatusTerminated
Product CodeFMT
Date Initiated2009-07-17
Date Terminated2011-06-01
Product Quantity6489 units

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.

Firm 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.

Root Cause

Equipment maintenance

Distribution Pattern

Worldwide distribution: USA, Brazil, Canada, China, Dominican Republic, France, Korea, Lebanon, Mexico, Nigeria, Panama, Poland, Saudi Arabia, Taiwan, Turkey, United Kingdom, Uruguay, and Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042607PRIMUS USDraeger Medical, Inc. · 2004-11-26K913945STABILET INFANT RADIANT WARMER MODEL 2000CHill-Rom, Inc. · 1992-02-12K850069BORNING NEONATAL RESUSCITATOIN CENTERBorning Corp. · 1985-05-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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