Puritan Bennett 840 Series Ventilator Power Supply Model/Catalog Numbers: 4-076314-00; 4-076314-SP
FDA device recall Z-1085-05 · posted 2005-08-06 · Terminated
Recall details
- Recalling firm
- Puritan Bennett
- Reason for recall
- Manufacturing defect at contract manufacturer, employee error, poor training, improper inspection.
- Action taken
- Recall is by letter sent Fedex 4/20/05. After two weeks nonrespondants will be telephoned. Foreign customers will be handled by firm''s local offices similarly.
- Root cause
- Other
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 309
- Distribution
- USA, Canada and Europe.
- Date initiated
- 2005-04-20
- Date posted
- 2005-08-06
- Date terminated
- 2012-01-25
- Location
- Pleasanton, 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, 840 VENTILATOR SYSTEM (MODEL 840) (K970460) | Puritan Bennett Corp. | 1998-04-30 |