Recall Z-1692-2008 ยท CBK Ventilator, Continuous, Facility Use
Covidien Limited
Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS) Model 802, Puritan-Bennett Corporation, A subsidiary of Mallinckrodt Inc., Carlsbad, CA
| Date | Sep 16, 2008 (initiated Mar 21, 2008) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970460 | NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840) Puritan Bennett Corp., Apr 30, 1998 |