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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmDecember 16, 2004
Date PostedJanuary 28, 2005
Recall Status1 Terminated 3 on January 23, 2008
Recall NumberZ-0444-05
Recall Event ID 30779
510(K)NumberK964540 K984379 
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
ProductInternal Battery for Puritan Bennett 700 Series Ventilator.
Code Information All produced from 3/1/02 to 5/12/04
Recalling Firm/
Manufacturer		 Nellcor Puritan Bennett Inc
2200 Faraday Ave
Carlsbad CA 92008-7208
For Additional Information ContactPuritan Bennett Customer Service
800-635-5267
Manufacturer Reason
for Recall		Wires on battery may loosen causing disconnection.
FDA Determined
Cause 2		Other
ActionLetters will be Fedexed to customers which includes a simple test instruction that users can use to test the performance of the back up alarm.
Quantity in Commerce6642 (3680 in vents and 2962 as replacements)
DistributionNationwide, Europe, Japan, Latin America and other portions of Asia.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CBK
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