DeVilbiss iFill Personal Oxygen Station model number 535D.
This recall has been terminated (originally issued October 17, 2006).
- Company
- Sunrise Medical
- Recall Initiated
- August 24, 2006
- Posted
- October 17, 2006
- Terminated
- August 27, 2009
- Recall Number
- Z-0038-2007
- Quantity
- 252 units
- Firm Location
- Somerset, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for oxygen cylinders to not fill completely
Distribution
The product was distriubted to 252 end users nationwide through 36 dealers.
Lot / Code Info
serial numbers AD01145 through AD01462
Root Cause
Other
Action Taken
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.
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