Recall Z-0054-04 ยท BZD Ventilator, Non-Continuous (Respirator)
Western a Scott Fetzer Co
Western Medica OPC Portable Oxygen Conserving Regulator, Model OPC-830, 1/2 - 5 LPM, packaged under the Western Medica label.
| Date | Oct 24, 2003 (initiated Oct 2, 2003) |
| Status | Terminated |
| Reason | The demand valve is defective and does not function as intended in the 'Conservative Mode'. |
| Root cause | Other |
| Action | The firm notified the affected consignees by letter on 10/2/2003. Customers were asked to return the units for replacements. |
| Quantity | 329 units |
| Distribution | The device was distributed nationwide and into China and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010747 | OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830 Western Ent., May 16, 2001 |