Device product
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080060
Z-1959-2023
Product summary
- Firm
- TELEFLEX LLC
- Event
- Event 92373
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 4160 units
- Official record key
device-enforcement:Z-1959-2023
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: 18GG26, 18GT08, 18GT11, 18IG22, 18IT18, 18JG33, 19AG39, 19ET31, 19GT25, 19IT20, 19KT14, 19KT47, 20AT58, 20CT13, 20FT66, KME20J1463, KME21K0521, KME22A2893, KME22B2215, KME22C2044, KME22G2998, KME22J0859
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.