Device product
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780085
Z-1949-2023
Product summary
- Firm
- TELEFLEX LLC
- Event
- Event 92373
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 670 units
- Official record key
device-enforcement:Z-1949-2023
Official wording
Reason: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Code information: UDI/DI 14026704341136, Batch Numbers: 18GG25, 18LG18, 19AG19, 19DT36, 20CT32, 20GT34, KME21B2675, KME21F0887, KME22H1797
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.