FDA Medical Device Recalls (openFDA)
Covidien Limited: Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS) Model 802, Puritan-Bennett Corporation, A subsidiary of Mallinckrodt Inc., Carlsbad, CA
- Recall number
- Z-1692-2008
- Recalling firm
- Covidien Limited
- Product
- Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS) Model 802, Puritan-Bennett Corporation, A subsidiary of Mallinckrodt Inc., Carlsbad, CA
- Status
- Terminated
- Initiated
- 2008-03-21
- Posted
- 2008-09-16
- Terminated
- 2008-10-29
- Reason
- Wiring in battery back-up power supply may short and cause thermal damage to ventilator.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 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.
- Lot, serial or model codes
- 4-070523-SP Battery Assembly 4-840120DIUU-US 4-070520-SP BPS
- 510(k) numbers
- K970460
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 2936999
- Firm city
- Boulder
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28