FDA Recall
Terminated
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.]
Recall: Z-0310-05
·
Initiated October 29, 2004
Recall
- Recall Number
- Z-0310-05
- Event Number
- 30357
- Firm
- Medtronic Xomed, Inc.
- FEI Number
- 1045254
- Product Code
- ETN
- Status
- Terminated
- Root Cause
- Other
- Initiated
- October 29, 2004
- Posted
- December 15, 2004
- Terminated
- July 7, 2012
- Address
- 6743 Southpoint Dr N, Jacksonville, FL, 32216-6218
Description
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.]
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.
Distribution
Distributed nationwide and worldwide. to countries in the five continents with the highest populations.
Quantity
22569 EMG Tubes