Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170125
FDA Recall #Z-1838-2023 — Class I — May 25, 2023
Product Description
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170125
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
18900 units
Distribution
US Nationwide distribution including Puerto Rico.
Code Information
UDI/DI 14026704644886, Batch Numbers: 18JG11, 18JG26, 18JG34, 18KG18, 18KG23, 18LG15, 18LG22, 19AG09, 19AG21, 19AG24, 19AG37, 19BG04, 19BG07, 19BG12, 19BG16, 19BG21, 19CT41, 19CT49, 19CT55, 19DT38, 19ET45, 19ET77, 19FT24, 19GT59, 19HT35, 20CT51, 20DT37, 20ET16, 20ET28, 20GG41, 20GG45, KME20J0332, KME20K0948, KME20K2546, KME20L0629, KME20L0630, KME20L0631, KME20L1484, KME20L2399, KME20M0810, KME21A1887, KME21A1888, KME21B0577, KME21B1142, KME21C0490, KME21C3427, KME21C3428, KME21D1022, KME21K1724, KME21K1725, KME21K1726, KME21L1891, KME21L1892, KME21M0433, KME21M1817, KME22B0724, KME22B0929, KME22B1072, KME22C0912, KME22D0786, KME22D3646, KME22D3647, KME22E1131, KME22E1237, KME22E2262, KME22F2865, KME22F2867, KME22G0565, KME22G1099, KME22G1517, KME22H1628, KME22H1899
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated