Device product
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080050
Z-1958-2023
Product summary
- Firm
- TELEFLEX LLC
- Event
- Event 92373
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 1750 units
- Official record key
device-enforcement:Z-1958-2023
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: 18FG07, 18JG33, 18JG36, 18LT16, 19CT26, 19KT38, 19LT07, 20AT41, 20CT13, 20ET17, KME20K1512, KME22B0593, KME22E2347, KME22H1178, KME22H3021
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.