Z-1693-2009

Heater Elements for Resuscitaire Infant Radiant Warmers model numbers RW82, RW82 VHA, WBR82, and WMRW82, 120...

Name: Z-1693-2009 Heater Elements for Resuscitaire Infant Radiant Warmers model numbers RW82, RW82 VHA, WBR82, and WMRW82, 120...
Creator: Draeger Medical Systems, Inc.
Published: 2009-07-29
License: https://open.fda.gov/license/

Draeger Medical Systems, Inc. / initiated 2009-07-29 / Terminated / root cause: manufacturing process

FDA source

Draeger Medical Systems, Inc. began a recall of Heater Elements for Resuscitaire Infant Radiant Warmers model numbers RW82, RW82 VHA, WBR82, and WMRW82, 120 volt configuration only on 2009-07-29. The reason FDA records is "Spark, flame and smoke: A mis-positioned crimp on heater element lead wire resulted in flame and smoke aerating from the top of the warmer assembly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1693-2009
Status: Terminated
Initiated: 2009-07-29
Posted: 2009-08-26
Terminated: 2010-10-13
Recalling firm: Draeger Medical Systems, Inc.
Product: Heater Elements for Resuscitaire Infant Radiant Warmers model numbers RW82, RW82 VHA, WBR82, and WMRW82, 120 volt configuration only.
Product code: FMT Warmer, Infant Radiant
Reason for recall: Spark, flame and smoke: A mis-positioned crimp on heater element lead wire resulted in flame and smoke aerating from the top of the warmer assembly.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Draeger Medical issued an Urgent Medical Device Recall letter via certified mail on 8/7/09. The letter explained the problem, the need to conduct an inspection of the infant warmer (instructions included), and request replacement elements.
Quantity in commerce: 2915 elements
Distribution: Worldwide distribution: USA, Canada, Saudi Arabia, Bermuda, Virgin Islands, Mexico, Panama, Colombia, and Costa Rica.
Product codes and lots: Model numbers RW82, RW82 VHA, WBR82, and WMRW82. Date codes ending in 07

Product code FMT

K003335Class IIResuscitaire Radiant Warmer; Resuscitaire Birthing Room Warmer; Resuscitair Wall Mounted Radiant WarmerHill-Rom Air-Shields / cleared 2000-11-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)