Device product
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504590
Z-1853-2023
Product summary
- Firm
- TELEFLEX LLC
- Event
- Event 92373
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 13710 units
- Official record key
device-enforcement:Z-1853-2023
Official wording
Reason: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Code information: UDI/DI 4026704547654, Batch Numbers: 18FG18, 18FG20, 18GG17, 18GT32, 18HG12, 18HG27, 18HG38, 18IG15, 18IG30, 18KG03, 18KG07, 18KG35, 18LG18, 19AG24, 19AG27, 19BG04, 19DT38, 19DT45, 19ET32, 19ET72, 19FT14, 19GT20, 19HT40, 19IT39, 19IT58, 19KT17, 19KT21, 19LT50, 20BG16, 20BT05, 20BT47, 20CT36, 20CT44, KME20H0238, KME20H0239, KME20H0591, KME20J2420, KME21E1114, KME22B1404, KME22B1405, KME22B1755, KME22C0915, KME22C1943, KME22C2372, KME22D1717, KME22D1718, KME22G1443, KME23A2760, KME23C0137
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.