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U.S. Department of Health and Human Services

Class 2 Device Recall DeVilbiss 535DX CF Continuous Flow Cylinder (Oxygen)

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  Class 2 Device Recall DeVilbiss 535DX CF Continuous Flow Cylinder (Oxygen) see related information
Date Initiated by Firm January 24, 2007
Date Posted April 21, 2007
Recall Status1 Terminated 3 on August 27, 2009
Recall Number Z-0732-2007
Recall Event ID 37189
510(K)Number K020329  
Product Classification Oxygen cylinders - Product Code NFB
Product 535D-X CF Continuous Flow Cylinder
Code Information Model 535D-M6-CF, serial numbers 06195A051 through 06276B225; Model 535D-ML6-CF, serial numbers 06198A026 through 06277B196; Model 535D-C-CF, serial numbers 06230A008 through 06230A124; Model 535D-D-CF, serial numbers 06230A001 through 06262B126; and Model 535D-E-CF, serial numbers 06230A055 through 06313B122.
Recalling Firm/
Manufacturer		 Sunrise Medical
100 Devilbiss Dr
Somerset PA 15501-2125
For Additional Information Contact Joseph E. Olsavsky
814-443-7690
Manufacturer Reason
for Recall		 Cylinder could lose oxygen at high pressure after the filling process
FDA Determined
Cause 2		 Other
Action The recalling firm began to notify customer via telephone on 1/24/07. An ''Urgent Medical Device Recall Letter'' was sent on 1/29/07. Customers were advised what model and serial numbers were affected and how to contact the firm and/or dealer to have the unit replaced. The recalling firm identified additional serial numbers that were involved in the recall therefore another Urgent Medical Device Recall Letter dated 6/12/07 was sent to the customers that received the addiitonal units.
Quantity in Commerce 4,169 units (Z-0731/0732-2007)
Distribution Worldwide-original shipments to distributors/dealers USA and Canada.
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 = NFB and Original Applicant = SUNRISE MEDICAL HHG, INC.
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