Recall Z-1089-2008 ยท MNR Ventilatory Effort Recorder
Respironics, Inc.
Stardust Flexible Y Sensor Probe model number 612054. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
| Date | Apr 24, 2008 (initiated Oct 15, 2007) |
| Status | Terminated |
| Reason | Foreign material: Glass fragments may present in the plastic bag material used to ship components. |
| Root cause | Environmental control |
| Action | The recalling firm issued a Recall Notification dated 10/18/07 to its customers. Replacement products were to be sent. |
| Quantity | 20950 units |
| Distribution | The products were shipped nationwide to medical facilities. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052573 | STARDUST II Respironics, Inc., Dec 13, 2005 |