Recall Z-1086-2008 ยท NPF Monitor, Apnea, Home Use
Respironics, Inc.
APNEA monitor accessories under the following brand names: a) SM 2 PS/PSL, Prof. Operators Manual, NL-NL model number 1025422; b) SM 2/2 PS Europe Patient Cable, Metal model number 1030194; and c) Smartmonitor 2 with modem, PCMCIA model number 4003. 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
| K061256 | SMARTMONITOR 2PS Respironics, Inc., Aug 2, 2006 |