The LTV Series ventilators provides continuous or intermittent ventilatory support for the care of individuals who requi
FDA device recall Z-1485-04 · posted 2004-09-28 · Terminated
Recall details
- Recalling firm
- Cardinal Health 203, Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 10,299 ventilators
- Distribution
- Nationwide and worldwide
- Date initiated
- 2004-09-08
- Date posted
- 2004-09-28
- Date terminated
- 2008-05-28
- Location
- Minneapolis, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LTV-1000 VENTILATOR (K032226) | Pulmonetic Systems, Inc. | 2003-10-16 |
| MODIFICATION TO LAP TOP VENTILATOR (LTV) (K010608) | Pulmonetic Systems, Inc. | 2001-03-20 |
| VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000 (K002881) | Pulmonetic Systems, Inc. | 2000-10-11 |
| LTV 1000 (K984056) | Pulmonetic Systems, Inc. | 1999-04-12 |
| LTV 1000 VENTILATOR (K981371) | Pulmonetic Systems, Inc. | 1998-10-30 |