535D-X CF Continuous Flow Cylinder
FDA device recall Z-0732-2007 · posted 2007-04-21 · Terminated
Recall details
- Recalling firm
- Sunrise Medical
- Reason for recall
- Cylinder could lose oxygen at high pressure after the filling process
- Action taken
- The recalling firm began to notify customer via telephone on 1/24/07. An ''Urgent Medical Device Recall Letter'' was sent on 1/29/07. Customers were advised what model and serial numbers were affected and how to contact the firm and/or dealer to have the unit replaced. The recalling firm identified additional serial numbers that were involved in the recall therefore another Urgent Medical Device Recall Letter dated 6/12/07 was sent to the customers that received the addiitonal units.
- Root cause
- Other
- Status
- Terminated
- Product code
- NFB
- Quantity affected
- 4,169 units (Z-0731/0732-2007)
- Distribution
- Worldwide-original shipments to distributors/dealers USA and Canada.
- Date initiated
- 2007-01-24
- Date posted
- 2007-04-21
- Date terminated
- 2009-08-27
- Location
- Somerset, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DEVILBISS PD1000 (K020329) | Sunrise Medical Hhg, Inc. | 2002-06-19 |