Device product
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080080
Z-1963-2023
Product summary
- Firm
- TELEFLEX LLC
- Event
- Event 92373
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 3843 units
- Official record key
device-enforcement:Z-1963-2023
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: 18FG02, 18GG15, 18IG13, 18IG22, 18JG17, 18JG38, 19BG21, 19DT19, 19GT24, 19HT26, 19JT20, 19KT19, 19KT38, 19KT50, 19LT46, 19LT47, 20AT06, 20BT09, 20DT23, 20GG39, KME21G0866, KME22A2268, KME22B0062
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.