Recall Z-0743-2022 ยท ETN Stimulator, Nerve
Medtronic Xomed, Inc.
NIM TRIVANTAGE EMG Endotracheal Tube
| Date | Dec 22, 2021 |
| Status | Open, Classified |
| Reason | There is potential for multiple issues due to a manufacturing nonconformity. |
| Root cause | Process control |
| Action | Medtronic will distribute a removal notice to impacted U.S. consignees, on 22-Dec-2021. A second attempt to notify US consignees is scheduled for the week of 02-Feb-2022. A third attempt to notify US consignees is scheduled for the week of 16-Mar-2022. Consignees are asked to take the following actions immediately: 1) Do NOT use any impacted product. Remove and quarantine all unused impacted product(s) in your inventory. 2) Return the impacted product(s) to Medtronic. Your Medtronic representative can assist in facilitating the return of the product as necessary. If an alternative product |
| Quantity | 301,926 devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Faroe Islands, Finland, France, French G |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112686 | NEXT GEN EMG ENDOTRACHEAL TUBE Medtronic Xomed, Inc., Jun 27, 2012 |