Events

Recall of Device Recall Heater Elements for Resuscitaire Infant Radiant Warmers

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Draeger Medical Systems, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    52835
  • Event Risk Class
    Class 2
  • Event Number
    Z-1693-2009
  • Event Initiated Date
    2009-07-29
  • Event Date Posted
    2009-08-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84109
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Heater Element for Infant Radiant Warmer - Product Code FMT
  • Reason
    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.
  • 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.

Device

Device Recall Heater Elements for Resuscitaire Infant Radiant Warmers
  • Model / Serial
    Model numbers RW82, RW82 VHA, WBR82, and WMRW82. Date codes ending in 07
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, Canada, Saudi Arabia, Bermuda, Virgin Islands, Mexico, Panama, Colombia, and Costa Rica.
  • Product Description
    Heater Elements for Resuscitaire Infant Radiant Warmers model numbers RW82, RW82 VHA, WBR82, and WMRW82, 120 volt configuration only.
  • Manufacturer
    Draeger Medical Systems, Inc.

Manufacturer

Draeger Medical Systems, Inc.
  • Manufacturer Address
    Draeger Medical Systems, Inc., 3135 Quarry Rd, Telford PA 18969-1042
  • Manufacturer Parent Company (2017)
    Stefan Dräger GmbH
  • Source
    USFDA