Recall Z-0732-2007 ยท NFB Conserver, Oxygen
Sunrise Medical
535D-X CF Continuous Flow Cylinder
| Date | Apr 21, 2007 (initiated Jan 24, 2007) |
| Status | Terminated |
| Reason | Cylinder could lose oxygen at high pressure after the filling process |
| Root cause | Other |
| Action | 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. |
| Quantity | 4,169 units (Z-0731/0732-2007) |
| Distribution | Worldwide-original shipments to distributors/dealers USA and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020329 | DEVILBISS PD1000 Sunrise Medical Hhg, Inc., Jun 19, 2002 |