Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS) Model 802, Puritan-Bennett Corporation, A subsidiary of Mallinckrodt Inc., Carlsbad, CA
FDA Recall Z-1692-2008 · Posted 2008-09-16
Recalling FirmCovidien Limited
Recall StatusTerminated
Product CodeCBK
Date Initiated2008-03-21
Date Terminated2008-10-29
Product Quantity6 Ventilators and 151 factory replacement units
Reason for Recall
Wiring in battery back-up power supply may short and cause thermal damage to ventilator.
Firm 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.
Root Cause
Process control
Distribution Pattern
Nationwide, including one VA facility in IL and two military facilities in NC and NY. No foreign distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.