Device product
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780050
Z-1943-2023
Product summary
- Firm
- TELEFLEX LLC
- Event
- Event 92373
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 19842 units
- Official record key
device-enforcement:Z-1943-2023
Official wording
Reason: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Code information: UDI/DI 14026704341068, Batch Numbers: 18FG12, 18FG24, 18GG03, 18GT26, 18HG24, 18IG24, 18JG07, 18KG34, 18LG11, 18LG31, 19AG09, 19AG11, 19AG21, 19AG36, 19CG07, 19CT36, 19DT06, 19FT18, 19GT44, 19JT01, 19KT37, 19LT04, 19LT32, 20AT09, 20BT53, 20CT24, 20DT24, 20ET50, 20ET56, 20FT36, 20FT58, KME20J1117, KME20M0952, KME21A0202, KME21A2486, KME21B0747, KME21C0326, KME22A1676, KME22B0553, KME22B1725, KME22C2818, KME22D0293, KME22D2681, KME22F0733, KME22G0349, KME22G3043, KME22H1792, KME22J2836, KME22K0470, KME22K0876, KME22M1319, KME22M1954, KME23A0157, KME23A1282, KME23A1422, KME23A1483, KME23A2002, KME23A2278, KME23B0506
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.