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U.S. Department of Health and Human Services

Class 2 Device Recall PuritanBennett 800 Series Ventilator Backup Power Source Model 802

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 Class 2 Recall
PuritanBennett 800 Series Ventilator Backup Power Source Model 802
see related information
Date Posted September 16, 2008
Recall Status1 Terminated on October 29, 2008
Recall Number Z-1692-2008
Recall Event ID 47523
Premarket Notification
510(K) Number
K970460 
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS) Model 802, Puritan-Bennett Corporation, A subsidiary of Mallinckrodt Inc., Carlsbad, CA
Code Information 4-070523-SP Battery Assembly 4-840120DIUU-US 4-070520-SP BPS
Recalling Firm/
Manufacturer
Covidien Limited
6135 Gunbarrel Ave
Boulder, Colorado 80301-3214
Manufacturer Reason
for Recall
Wiring in battery back-up power supply may short and cause thermal damage to ventilator.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = PURITAN BENNETT CORP.
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