Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504590
FDA Recall #Z-1853-2023 — Class I — May 25, 2023
Product Description
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504590
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
13710 units
Distribution
US Nationwide distribution including Puerto Rico.
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated