Recall Z-0310-05 ยท ETN Stimulator, Nerve
Medtronic Xomed, Inc.
Brand name: NIM EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29108 NIM EMG Reinforced Endotracheal Tube REF 82-29306, 82-29307, 82-29308 [All products are packaged one unit per box.]
| Date | Dec 15, 2004 (initiated Oct 29, 2004) |
| Status | Terminated |
| Reason | The firm received six reports of tubes with wires 'out of channel' two of which involved injuried patients. In one case in Germany it was reported that the patient had soreness of the throat and was discharged after four days. In the next case the patient had a tracheal wound. It was not clear what caused the wound. |
| Root cause | Other |
| Quantity | 22569 EMG Tubes |
| Distribution | Distributed nationwide and worldwide. to countries in the five continents with the highest populations. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K925640 | XOMED-TREACE EMG ENDOTRACHEAL TUBEEN Xomed-Treace, Inc., Aug 17, 1993 |