Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-1693-2009 · Posted 2009-08-26

Recalling FirmDraeger Medical Systems, Inc.
Recall StatusTerminated
Product CodeFMT
Date Initiated2009-07-29
Date Terminated2010-10-13
Product Quantity2915 elements

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

Worldwide distribution: USA, Canada, Saudi Arabia, Bermuda, Virgin Islands, Mexico, Panama, Colombia, and Costa Rica.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K003335RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMERHill-Rom Air-Shields · 2000-11-17

Official Source

View FDA Recall →

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

↑