FDA Medical Device Recalls (openFDA)
Draeger Medical, Inc.: Carina Home Ventilator. The device is used as a continuous respirator/ventilator for home use.
- Recall number
- Z-1263-2009
- Recalling firm
- Draeger Medical, Inc.
- Product
- Carina Home Ventilator. The device is used as a continuous respirator/ventilator for home use.
- Status
- Terminated
- Initiated
- 2009-01-21
- Posted
- 2009-05-14
- Terminated
- 2010-01-05
- 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.
- Root cause
- Software design
- Action
- An "Urgent - Medical Device Recall" Letter dated January 2009 was issued to consignees via certified mail. The letter described the issue, specific conditions, background information, and precautions for customers. An additional letter dated January 22, 2009 was included with the "Urgent - Medical Device Recall" letter which instructed consignees to inform an enduser of the contents of the notification letter because some of the consignees are home care device/service providers. When the new hardware/software solution is available, affected devices will be updated free of charge. Direct questions about the notification letter to Drager Medical, Inc. by calling 1-800-543-5047 (press "1" at the prompt and then press "2349#"). Direct questions regarding updating your device when the new software is available, contact Drager Service Technical Support at 1-800-543-5047 (press "4" at the prompt).
- Quantity
- 40 units
- Distribution
- Nationwide Distribution -- states of CA, FL, GA, HI, IL, LA, MA, MN, OH, and TX.
- Lot, serial or model codes
- Catalog Numbers 5704757 and 5704758.
- 510(k) numbers
- ["K060705"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 2517967
- Firm city
- Telford
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28