Device product
Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506545
Z-1858-2023
Product summary
- Firm
- TELEFLEX LLC
- Event
- Event 92373
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 12400 units
- Official record key
device-enforcement:Z-1858-2023
Official wording
Reason: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Code information: UDI/DI 4026704547708, Batch Numbers: 18FG05, 18FG13, 18GG20, 18HG16, 18IG06, 18IG12, 18JG04, 18JG14, 18JG21, 18JG34, 18KG35, 18LG02, 18LG18, 18LG28, 19BG21, 19CT49, 19FT35, 19GT20, 19GT28, 19GT38, 19GT59, 19GT65, 19HT24, 19HT80, 19IT29, 19KT25, 19KT48, 19LT38, 20AT09, 20BG16, 20BT05, 20CT05, 20CT36, 20CT44, 20DT37, 20GG45, KME20H2927, KME20H2928, KME20K2248, KME20L0620, KME20L1471, KME20L1472, KME20L2030, KME20M2482, KME21A1892, KME21A1893, KME21A2811, KME21B0576, KME22G3102, KME22J2956, KME22K2778, KME22L3057, KME23A2083, KME23B1203
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.