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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 Device Recall PuritanBennett 800 Series Ventilator Backup Power Source Model 802 see related information
Date Initiated by Firm March 21, 2008
Date Posted September 16, 2008
Recall Status1 Terminated 3 on October 29, 2008
Recall Number Z-1692-2008
Recall Event ID 47523
510(K)Number K970460  
Product Classification Ventilator - 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 CO 80301-3214
For Additional Information Contact
303-305-2382
Manufacturer Reason
for Recall		 Wiring in battery back-up power supply may short and cause thermal damage to ventilator.
FDA Determined
Cause 2		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = PURITAN BENNETT CORP.
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