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U.S. Department of Health and Human Services

Class 2 Device Recall Puritan Bennett Ventilator System

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  Class 2 Device Recall Puritan Bennett Ventilator System see related information
Date Initiated by Firm December 17, 2004
Date Posted January 28, 2005
Recall Status1 Terminated 3 on January 23, 2008
Recall Number Z-0445-05
Recall Event ID 30785
510(K)Number k964540  k984379  
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product Model 740 and 760 series Ventilators.
Code Information All units ever manufactured. The product may be identified and tracked through serial numbers. This is a tracked device.
Recalling Firm/
Manufacturer		 Nellcor Puritan Bennett Inc
2200 Faraday Ave
Carlsbad CA 92008-7208
For Additional Information Contact Puritan Bennett Customer Service
800-635-5267
Manufacturer Reason
for Recall		 Capacitor weakness in backup alarm system might fail causing lack of backup alarm to function in the event of total power loss.
FDA Determined
Cause 2		 Other
Action Customers of record will be notified by letter sent FEDEX, a simple test instruction will be included to use to test the performance of the backup alarm.
Quantity in Commerce 13,010 worldwide, 3,948 in USA and territories.
Distribution Worldwide.
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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