Device product
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080065
Z-1960-2023
Product summary
- Firm
- TELEFLEX LLC
- Event
- Event 92373
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 6710 units
- Official record key
device-enforcement:Z-1960-2023
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: 18GT07, 18HG20, 18IG16, 18IG22, 18JG13, 19AT23, 19CT64, 19ET12, 19ET31, 19HT69, 19LT47, 20AT41, 20BT13, 20DT40, 20GT05, KME22A2193, KME22A2546, KME22B2739, KME22C2271, KME22E0189
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.