Date Recall Initiated |
June 8, 2001 |
---|---|
Product: |
ESPRIT Ventilator Model V1000 |
Use: |
The device is a computer controlled, electrically powered, mechanical ventilator. It is intended to provide ventilatory support for adult and pediatric patients suffering breathing distress. |
Recalling Firm: |
Respironics California, Inc. 2271 Cosmos Ct. Carlsbad, California 92009 |
Reason for Recall: |
A material used to construct three check-valves in this ventilator predisposed them to premature failure. There have been two patient injuries resulting in partial or complete failure to permit ventilation. |
Public Contact: |
Kathy Moore Director, Quality Assurance/Regulatory Affairs 760-918-7321 |
FDA District: |
Los Angeles |
FDA Comment: |
There is a reasonable probability that use of the product presents a risk of serious adverse health consequences, including death. For additional information on this product recall, see the FDA Enforcement
Report located at: http://www.fda.gov/bbs/topics/Enforce/2003/ENF00803.html
Scroll down to "Recalls and Field Corrections: Devices – Class
I" |
Updated July 10, 2003
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