Device product
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780060
Z-1945-2023
Product summary
- Firm
- TELEFLEX LLC
- Event
- Event 92373
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 16570 units
- Official record key
device-enforcement:Z-1945-2023
Official wording
Reason: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Code information: UDI/DI 14026704341082, Batch Numbers: 18FG12, 18FG23, 18GG03, 18GT26, 18HG24, 18JG14, 18KG08, 18KG22, 18LG31, 19AG09, 19AG11, 19AG21, 19DT42, 19ET34, 19FT18, 19GT44, 19HT66, 19JT01, 19JT20, 19KT17, 19LT04, 19LT08, 19LT31, 19LT32, 20AT09, 20CT23, 20DT29, KME20L1712, KME20M0352
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.