Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS) Model 802, Puritan-Bennett Corporation, A subsidiary of Mallinckrodt Inc., Carlsbad, CA
This recall has been terminated (originally issued September 16, 2008).
- Company
- Covidien Limited
- Recall Initiated
- March 21, 2008
- Posted
- September 16, 2008
- Terminated
- October 29, 2008
- Recall Number
- Z-1692-2008
- Quantity
- 6 Ventilators and 151 factory replacement units
- Firm Location
- Boulder, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Wiring in battery back-up power supply may short and cause thermal damage to ventilator.
Distribution
Nationwide, including one VA facility in IL and two military facilities in NC and NY. No foreign distribution.
Lot / Code Info
4-070523-SP Battery Assembly 4-840120DIUU-US 4-070520-SP BPS
Root Cause
Process control
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.