Recall Z-0901-2017 ยท ETN Stimulator, Nerve
Medtronic Xomed, Inc.
NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.
| Date | Jun 28, 2016 |
| Status | Terminated |
| Reason | Wire in tubing can become exposed, posing potential harm to the intubated patient. |
| Root cause | Use error |
| Action | Medtronic sent an Urgent Product Safety Advisory letter dated June 28, 2016, to all affected customers informing them of the correction and providing instruction to avoid causing injury when using the EMG Endotracheal Tube. Recommended Actions included: inspecting the product thoroughly before use, testing the cuff by inflating it then deflating it before intubation, using a non-malleable stylet that closely matches the natural curve of the tube, not bending and flexing the tube excessively before use, and lubricating the cuff with a non-paralyzing, aqueous lubricant and a lubricated stylet. |
| Quantity | 3752 |
| Distribution | Worldwide Distribution - Nationwide Distribution including US Virgin Island and Puerto Rico , and to the countries of :Japan, Korea, China, Canada, Dominican Republic, Colombia, Chile, Costa Rica, Bahamas, Peru, Panama, Mexico, Argentina, Ecuador, Brazil, Trinidad and Tobago, Hong Kong, Taiwan, Uni |
| 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 |