Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS) Model 802, Puritan-Bennett Corporation, A subsidiary of
FDA device recall Z-1692-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- Covidien Limited
- Reason for recall
- Wiring in battery back-up power supply may short and cause thermal damage to ventilator.
- Action taken
- All customers were notified by Federal Express letter and were contacted by phone through field service engineers. They were told to examine their inventory for any installed or spare part battery assemblies and to remove and quarantine these parts. Any ventilators with installed affected battery assemblies were to be taken out of service.
- Root cause
- Process control
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 6 Ventilators and 151 factory replacement units
- Distribution
- Nationwide, including one VA facility in IL and two military facilities in NC and NY. No foreign distribution.
- Date initiated
- 2008-03-21
- Date posted
- 2008-09-16
- Date terminated
- 2008-10-29
- Location
- Boulder, CO
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 |