Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall see related information
Date Initiated by Firm December 16, 2004
Date Posted January 28, 2005
Recall Status1 Terminated 3 on January 23, 2008
Recall Number Z-0444-05
Recall Event ID 30779
510(K)Number k964540  k984379  
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product Internal 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 Contact Puritan Bennett Customer Service
800-635-5267
Manufacturer Reason
for Recall		 Wires on battery may loosen causing disconnection.
FDA Determined
Cause 2		 Other
Action Letters 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 Commerce 6642 (3680 in vents and 2962 as replacements)
Distribution Nationwide, Europe, Japan, Latin America and other portions of Asia.
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.
-
-