Company: Draeger Medical, Inc
Date of Enforcement Report 5/20/2009
Class:ll
PRODUCT
Carina Home Ventilator. The device is used as a continuous respirator/ventilator for home use. Catalog Numbers 5704757 and 5704758. Recall # Z-1263-2009
REASON
The device may not generate a pilot line disconnect alarm if the pilot line becomes disconnected, which may potentially result in a substantial reduction in tidal volume delivery.
RECALLING FIRM/MANUFACTURER
Draeger Medical, Inc. Telford, PA, by letters dated January 2009 and January 22, 2009.
Manufacturer: Drager HomeCare, Best, Netherlands. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
40 units
DISTRIBUTION
CA, FL, GA, HI, IL, LA, MA, MN, OH, and TX
