Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506530
FDA Recall #Z-1855-2023 — Class I — May 25, 2023
Product Description
Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506530
Reason for Recall
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Recalling Firm
TELEFLEX LLC — Morrisville, NC
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
32553 units
Distribution
US Nationwide distribution including Puerto Rico.
Code Information
UDI/DI 4026704547678, Batch Numbers: 18FG05, 18GG12, 18GG17, 18GG31, 18GT32, 18HG12, 18HG16, 18IG02, 18IG06, 18IG15, 18IG21, 18IG27, 18JG02, 18JG23, 18JG32, 18JG34, 18KG15, 18KG23, 18LG02, 18LG22, 18LG28, 19AG21, 19AG24, 19AG27, 19AG37, 19BG25, 19BG40, 19CT65, 19ET72, 19FT01, 19GT05, 19GT20, 19GT59, 19GT65, 19HT40, 19HT61, 19HT80, 19IT29, 19IT39, 19JT18, 19JT22, 19JT29, 19JT49, 19JT57, 19KT08, 19LT04, 19LT48, 20AT09, 20AT32, 20AT44, 20AT46, 20AT53, 20BT23, 20BT37, 20BT47, 20CT05, 20CT12, 20CT36, 20DT37, 20ET16, 20ET28, KME20J0318, KME20K0152, KME20K0153, KME20K0154, KME20K3587, KME20L1467, KME20L1468, KME20L1838, KME20M2048, KME20M2480, KME21A0669, KME21A1897, KME21A2807, KME21B1674, KME21B1675, KME21C0489, KME21M0865, KME21M2740, KME21M2741, KME22B2144, KME22B2326, KME22B2327, KME22C1075, KME22C1826, KME22C3192, KME22D0787, KME22E0223, KME22E1029, KME22F0563, KME22G0910, KME22G0911, KME22H0780, KME22H2909, KME22J0577, KME22K0015, KME22K0016, KME22K0202, KME22K0335, KME22K0918
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated