Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780070
FDA Recall #Z-1947-2023 — Class I — May 25, 2023
Product Description
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780070
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
25520 units
Distribution
US Nationwide distribution including Puerto Rico.
Code Information
UDI/DI 14026704341105, Batch Numbers: 18FG12, 18FG24, 18GG01, 18GG26, 18GT26, 18HG36, 18IG14, 18IT05, 18JG07, 18KG10, 18KG34, 18LG11, 18LG31, 19AG36, 19CG07, 19CT69, 19ET12, 19GT39, 19GT44, 19HT80, 19IT12, 19IT43, 19JT01, 19JT55, 19KT21, 19LT08, 19LT31, 20AT13, 20AT49, 20BT53, 20CT24, 20DT09, 20DT24, 20ET50, 20FT39, 20FT59, 20GG27, KME20J2813, KME20J3155, KME20K1111, KME20K2068, KME20K3244, KME20L0730, KME20L0731, KME20L1681, KME20M0276, KME20M0955, KME20M2655, KME21A0979, KME21B0096, KME21B0154, KME21B1518, KME21C0334, KME21M1046, KME22A0450, KME22A1594, KME22B0425, KME22B1002, KME22C0473, KME22D1110, KME22D2351, KME22D2363, KME22D3366, KME22D3379, KME22E1102, KME22E2443, KME22F1333, KME22G0171, KME22G1728, KME22G3156, KME22H0815, KME22H1321, KME22J0749, KME22K1286, KME22K2440, KME22L1550, KME22L1660, KME22L2544
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated