Recall Z-0038-2007
Sunrise Medical · initiated August 24, 2006
Product
DeVilbiss iFill Personal Oxygen Station model number 535D.
Codes / lots: serial numbers AD01145 through AD01462
Reason for recall
Potential for oxygen cylinders to not fill completely
FDA-determined 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.
Details
- Recall number
- Z-0038-2007
- Initiated
- August 24, 2006
- Posted by FDA
- October 17, 2006
- Terminated
- August 27, 2009
- Product code
- CAW – Generator, Oxygen, Portable
- Quantity
- 252 units
- Distribution
- The product was distriubted to 252 end users nationwide through 36 dealers.
- Recalling firm
- Sunrise Medical, Somerset, PA