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U.S. Department of Health and Human Services

Medical Devices

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Draeger Medical Inc., Stabilet Infant Warmer

Recall Class: Class I
Date Recall
Initiated:
July 17, 2009
Product:

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

These devices were manufactured from January 1, 1987 through December 31, 1998 and were distributed from December 1, 1987 through November 30, 1999.

Use: An infant warmer provides a controlled environment for the care and protection of infants.
Recalling Firm: Draeger Medical Systems, Inc.
3135 Quarry Road
Telford, Pennsylvania 18969-1042
Reason for Recall: These out-of-date devices may cause serious injury to infants or caregivers.
Public Contact:

The company may be contacted at 1-800-543-5047, (press 1 at the prompt and then 2349#) from 8:00 AM to 5:00 PM Eastern Time.

For more information, see Useful Links below.

FDA District: Philadelphia
FDA Comments:

On July 20, 2009, the company issued a press release to the media and sent a recall letter to all known customers. The letter:

  • explained the problem.
  • requested customers to:
    • remove the affected devices from service as soon as possible and replace them as necessary.
    • remove the heating element and the power cord to make the device unusable once removed from service.
  • emphasized these devices are NOT to be used, donated or sold for any other purpose.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

Useful Links: