Internal Battery for Puritan Bennett 700 Series Ventilator.
FDA device recall Z-0444-05 · posted 2005-01-28 · Terminated
Recall details
- Recalling firm
- Nellcor Puritan Bennett Inc
- Reason for recall
- Wires on battery may loosen causing disconnection.
- Action taken
- Letters will be Fedexed to customers which includes a simple test instruction that users can use to test the performance of the back up alarm.
- Root cause
- Other
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 6642 (3680 in vents and 2962 as replacements)
- Distribution
- Nationwide, Europe, Japan, Latin America and other portions of Asia.
- Date initiated
- 2004-12-16
- Date posted
- 2005-01-28
- Date terminated
- 2008-01-23
- Location
- Carlsbad, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM (K984379) | Puritan Bennett Corp. | 1998-12-10 |
| NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEM (K964540) | Puritan Bennett Corp. | 1997-11-14 |