TELEFLEX LLC: Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506550

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: 10600 units Lot/code info: UDI/DI 4026704547715, Batch Numbers: 18FG01, 18FG05, 18FG13, 18GG17, 18GG31, 18HG12, 18HG19, 18JG21, 18JG32, 18KG41, 18LG18, 18LG28, 19AG21, 19DT25, 19DT33, 19ET54, 19ET77, 19FT24, 19GT59, 19GT65, 19HT24, 19HT61, 19IT29, 19JT42, 19JT49, 19JT57, 19KT25, 20AT14, 20AT25, 20AT44, 20BT05, 20BT27, 20BT37, 20BT51, 20CT05, 20CT12, 20CT36, 20DT09, 20ET56, 20GT06, 20GT38, KME20H1790, KME20J2114, KME20J3032, KME20K1344, KME20L1842, KME20L1843, KME20L2299, KME20M2094, KME20M2483, KME21A2812, KME21B1693, KME21C0020, KME22B1976, KME22H3204

UPC codes

4026704547715

Source

Official record: FDA (Device enforcement) ↗

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