Device product
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080085
Z-1964-2023
Product summary
- Firm
- TELEFLEX LLC
- Event
- Event 92373
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 1280 units
- Official record key
device-enforcement:Z-1964-2023
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: 18IG19, 18KG26, 19CT61, 19GT31, 19JT19, 19KT38, 19LT17, 20CT02, 20DT23, 20ET17, 20GT57, KME22A1989
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.