FDA Medical Device Recalls (openFDA)
Cardinal Health 203, Inc: The LTV Series ventilators provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. This is a prescription medical device intended for use by personnel under the direction of a physician. The ventilator is suitable for use in institutional, home and transport settings.
- Recall number
- Z-1485-04
- Recalling firm
- Cardinal Health 203, Inc
- Product
- The LTV Series ventilators provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. This is a prescription medical device intended for use by personnel under the direction of a physician. The ventilator is suitable for use in institutional, home and transport settings.
- Status
- Terminated
- Initiated
- 2004-09-08
- Posted
- 2004-09-28
- Terminated
- 2008-05-28
- Reason
- Ventilators have not consistently switched to internal battery operation when the external DC power source has become inadequate to supply stable power. This situation results in loss of ventilation to the patient.
- Root cause
- Other
- Action
- A letter titled "Important Safety Information", dated September 7, 2004, was issued to all affected customers alerting them to the possibility of ventilator failure and providing instructions for recognizing and responding to the situation.
- Quantity
- 10,299 ventilators
- Distribution
- Nationwide and worldwide
- Lot, serial or model codes
- Recalled ventilators were manufactured prior to September 2003. Models LTV 1000, 950, 900, and 900 Model contain serial numbers less than A006500, C07000, B03500, and D01400, respectively.
- 510(k) numbers
- ["K032226","K981371","K984056","K010608","K002881"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 3002617992
- Firm city
- Minneapolis
- Firm state
- MN
- 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