Brand name: NIM EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29108 NIM EMG Reinforced Endotracheal Tube REF 82-29306
FDA device recall Z-0310-05 · posted 2004-12-15 · Terminated
Recall details
- Recalling firm
- Medtronic Xomed, Inc.
- Reason for recall
- 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
- Status
- Terminated
- Product code
- ETN
- Quantity affected
- 22569 EMG Tubes
- Distribution
- Distributed nationwide and worldwide. to countries in the five continents with the highest populations.
- Date initiated
- 2004-10-29
- Date posted
- 2004-12-15
- Date terminated
- 2012-07-07
- Location
- Jacksonville, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| XOMED-TREACE EMG ENDOTRACHEAL TUBEEN (K925640) | Xomed-Treace, Inc. | 1993-08-17 |