20
May
2009

Cl Il Carina Home Ventilator

0

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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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