FDA-Device2024-01-17Class II
NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c) 8229708, 8.0MM ID; d) 8229736, 6MM ID 3PK; e) 8229737, 7MM ID 3 PK; f) 8229738, 8MM ID 3 PK
Medtronic Xomed, Inc.
Hazard
Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,
Sold states
Worldwide distribution.
Affected count
80569 units
Manufactured in
6743 Southpoint Dr N, Jacksonville, FL, United States
Products
NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c) 8229708, 8.0MM ID; d) 8229736, 6MM ID 3PK; e) 8229737, 7MM ID 3 PK; f) 8229738, 8MM ID 3 PK
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0696-2024Don't want to check this manually?
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