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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 535Dsee related information
Date Initiated by FirmAugust 24, 2006
Date PostedOctober 17, 2006
Recall Status1 Terminated 3 on August 27, 2009
Recall NumberZ-0038-2007
Recall Event ID 36174
510(K)NumberK053240 
Product Classification Generator, Oxygen, Portable - Product Code CAW
ProductDeVilbiss iFill Personal Oxygen Station model number 535D.
Code Information serial numbers AD01145 through AD01462
FEI Number 2515872
Recalling Firm/
Manufacturer		 Sunrise Medical
100 Devilbiss Dr
Somerset PA 15501-2125
For Additional Information ContactJoseph Olsavsky
814-443-4881
Manufacturer Reason
for Recall		Potential for oxygen cylinders to not fill completely
FDA Determined
Cause 2		Other
ActionThe 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 Commerce252 units
DistributionThe product was distriubted to 252 end users nationwide through 36 dealers.
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 = CAW
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