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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm April 20, 2005
Date Posted August 06, 2005
Recall Status1 Terminated 3 on January 25, 2012
Recall Number Z-1085-05
Recall Event ID 31936
510(K)Number k970460  
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product Puritan Bennett 840 Series Ventilator Power Supply

Model/Catalog Numbers: 4-076314-00; 4-076314-SP
Code Information All codes
Recalling Firm/
Manufacturer		 Puritan Bennett
4280 Hacienda Dr
Pleasanton CA 94588-2719
For Additional Information Contact James Patrick Garvey
925-463-4479
Manufacturer Reason
for Recall		 Manufacturing defect at contract manufacturer, employee error, poor training, improper inspection.
FDA Determined
Cause 2		 Other
Action Recall is by letter sent Fedex 4/20/05. After two weeks nonrespondants will be telephoned. Foreign customers will be handled by firm''s local offices similarly.
Quantity in Commerce 309
Distribution USA, Canada and Europe.
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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