Recall Z-0038-2007 ยท CAW Generator, Oxygen, Portable
Sunrise Medical
DeVilbiss iFill Personal Oxygen Station model number 535D.
| Date | Oct 17, 2006 (initiated Aug 24, 2006) |
| Status | Terminated |
| Reason | Potential for oxygen cylinders to not fill completely |
| Root cause | 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 | 252 units |
| Distribution | The product was distriubted to 252 end users nationwide through 36 dealers. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053240 | DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES Sunrise Medical, Feb 3, 2006 |