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
- Recall Number
- Z-1485-04
- Event Number
- 29978
- Firm
- Cardinal Health 203, Inc
- FEI Number
- 3002617992
- Product Code
- CBK
- Status
- Terminated
- Root Cause
- Other
- Initiated
- September 8, 2004
- Posted
- September 28, 2004
- Terminated
- May 28, 2008
- Address
- 17400 Medina Rd, Ste 100, Minneapolis, MN, 55447-1341
Description
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.
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.
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.
Nationwide and worldwide
10,299 ventilators