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FDA (Device enforcement)Recalled 2023-05-25class i

TELEFLEX LLC: Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504570

Hazard

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Details from the source

Reason for recall: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. Distribution: US Nationwide distribution including Puerto Rico. Quantity: 1051810 units Lot/code info: UDI/DI 4026704547616, Batch Numbers: 18FG03, 18FG13, 18FG21, 18FG22, 18FG30, 18FT32, 18GG02, 18GG08, 18GG20, 18GT32, 18HG07, 18HG16, 18HG19, 18HG32, 18HG35, 18HG38, 18IG02, 18IG06, 18IG12, 18IG17, 18IG24, 18IG27, 18JG02, 18JG04, 18JG21, 18JG32, 18JG37, 18KG23, 18KG35, 18KG38, 18LG05, 18LG08, 18LG12, 18LG18, 18LG31, 18LG39, 19AG05, 19AG09, 19AG31, 19AG34, 19BG04, 19CG06, 19CT17, 19CT23, 19CT32, 19CT37, 19CT49, 19CT55, 19CT58, 19CT65, 19CT71, 19DT25, 19DT33, 19DT45, 19ET05, 19ET15, 19ET22, 19ET28, 19ET45, 19ET60, 19FT14, 19FT24, 19FT30, 19FT41, 19GT05, 19GT10, 19GT20, 19GT59, 19GT65, 19HT40, 19HT53, 19IT25, 19IT32, 19IT39, 19IT44, 19IT54, 19JT22, 19JT57, 19JT64, 19JT70, 19KT17, 19KT25, 19KT48, 19KT55, 19LT04, 19LT10, 19LT32, 19LT38, 19LT50, 20AT09, 20AT14, 20AT25, 20AT32, 20AT44, 20AT53, 20AT57, 20BG12, 20BT05, 20BT23, 20BT27, 20BT37, 20BT47, 20CT05, 20CT12, 20CT22, 20CT27, 20CT36, 20CT44, 20DT14, 20DT37, 20ET04, 20ET16, 20FT10, 20FT39, 20FT54, 20FT61, 20GG45, 20GG47, 20GT06, 20GT25, 20GT31, 20GT38, KME20H0972, KME20H1935, KME20H2588, KME20H2783, KME20J0058, KME20J0060, KME20J0156, KME20J0321, KME20J0573, KME20J0574, KME20J0803, KME20J0804, KME20J0805, KME20J0946, KME20J1112, KME20J1233, KME20J1692, KME20J1694, KME20J2175, KME20J2577, KME20J2957, KME20J3035, KME20K0026, KME20K0360, KME20K0361, KME20K0768, KME20K0941, KME20K1148, KME20K1202, KME20K1304, KME20K1552, KME20K1658, KME20K2057, KME20K2187, KME20K3161, KME20K3355, KME20L0057, KME20L0059, KME20L0490, KME20L0623, KME20L0

UPC codes

4026704547616

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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