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U.S. Department of Health and Human Services

Class 3 Device Recall DeVilbiss iFill Personal Oxygen Station model number 535D

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  Class 3 Device Recall DeVilbiss iFill Personal Oxygen Station model number 535D see related information
Date Initiated by Firm August 24, 2006
Date Posted October 17, 2006
Recall Status1 Terminated 3 on August 27, 2009
Recall Number Z-0038-2007
Recall Event ID 36174
510(K)Number K053240  
Product Classification Generator, Oxygen, Portable - Product Code CAW
Product DeVilbiss iFill Personal Oxygen Station model number 535D.
Code Information serial numbers AD01145 through AD01462
Recalling Firm/
Manufacturer		 Sunrise Medical
100 Devilbiss Dr
Somerset PA 15501-2125
For Additional Information Contact Joseph Olsavsky
814-443-4881
Manufacturer Reason
for Recall		 Potential for oxygen cylinders to not fill completely
FDA Determined
Cause 2		 Other
Action The recalling firm began to notify customers via telephone beginning on 8/24/06. An 'Urgent Medical Device Recall' letter was sent on 8/28/06. Customers were advised what model and serial numbers were affected and how to contact the firm and/or dealer to have the unit replaced. A customer service help line has been established (1-800-333-4000) to provide additional information for returning units.
Quantity in Commerce 252 units
Distribution The product was distriubted to 252 end users nationwide through 36 dealers.
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 = CAW and Original Applicant = SUNRISE MEDICAL
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