FDA recall Z-0696-2024

Product

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

Reason for recall

Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,

Distribution

Worldwide distribution.

Key facts

Status

Ongoing

Initiation date

2023-11-07

Report date

2024-01-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Jacksonville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0696-2024