Recall Z-0178-04 ยท BZD Ventilator, Non-Continuous (Respirator)
Respironics, Inc.
ComfortGel Nasal Mask size small
| Date | Dec 10, 2003 (initiated Sep 29, 2003) |
| Status | Terminated |
| Reason | product does not contain built in exhalation port |
| Root cause | Other |
| Action | The recalling firm telephoned the direct accounts to inform them of the problem and the need to return the product. |
| Quantity | 5293 units |
| Distribution | The products were shipped to sleep centers nationwide and in Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K954207 | GEL MASK Respironics, Inc., Jan 31, 1996 |