Recall Z-1091-2008 ยท NPF Monitor, Apnea, Home Use
Respironics, Inc.
Oximeter Patient Cable Masimo 8 ft model number H5870. 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
| K032403 | SMARTMONITOR 2 PROFESSIONAL SERIES (PS) Respironics, Inc., Oct 27, 2003 |