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FDA > CDRH > Medical Device Recalls > Class I Recall - Continuous Ventilator (Respirator)

Medical Device Recalls
Class I Recall: Continuous Ventilator (Respirator)

Date Recall Initiated:
December 22, 2000
Product:
Puritan-Bennett Ventilator, Model 840 containing Revision E-level software.
Use:
 To mechanically control or assist a patient's breathing by delivering a predetermined percent of oxygen in breathing gases. This device is used in hospital facilities.
Recalling Firm:
Puritan-Bennett Corporation
2200 Faraday Ave.
Carlsbad, California 92008
Reason for Recall:
Short bursts of breathing gases delivered at a high pressure may occur while using this device. These increases of pressure occurred with the Revision E version software.
Public Contact:
Puritan-Bennett Corporation
4280 Hacienda Dr.
Pleasanton, CA 94588
Phone: 925-463-4371
FDA District:
 Los Angeles, California
FDA Comment:
 FDA considers there to be a risk of over-pressure to the lungs (barotrauma) for patients whose weight is 20 kg (44 pounds) or less.

For additional information on this product recall, see the FDA Enforcement Report located at: http://www.fda.gov/bbs/topics/Enforce/2001/ENF00685.html. Scroll down to "Recalls and Field Corrections: Device - Class 1".

Updated November 5, 2001

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