DeVilbiss iFill Personal Oxygen Station model number 535D.
FDA device recall Z-0038-2007 · posted 2006-10-17 · Terminated
Recall details
- Recalling firm
- Sunrise Medical
- Reason for recall
- Potential for oxygen cylinders to not fill completely
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CAW
- Quantity affected
- 252 units
- Distribution
- The product was distriubted to 252 end users nationwide through 36 dealers.
- Date initiated
- 2006-08-24
- Date posted
- 2006-10-17
- Date terminated
- 2009-08-27
- Location
- Somerset, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES (K053240) | Sunrise Medical | 2006-02-03 |