Device product
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080090
Z-1965-2023
Product summary
- Firm
- TELEFLEX LLC
- Event
- Event 92373
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 670 units
- Official record key
device-enforcement:Z-1965-2023
Official wording
Reason: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Code information: UDI/DI 14026704341266, Batch Numbers: 18FT24, 18FT26, 19ET83, 19GT29, 19KT58, 19KT38
Distribution pattern: US Nationwide distribution including Puerto Rico.
Derived failure modes
-
Unknown
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.