Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380035
FDA Recall #Z-1927-2023 — Class I — May 25, 2023
Product Description
Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380035
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
2860 units
Distribution
US Nationwide distribution including Puerto Rico.
Code Information
UDI/DI 14026704340634, Batch Numbers: 18HG08, 18IG13, 18JG35, 18LG31, 19BG15, 19CT16, 19ET31, 19HT07, 19HT79, 19LT28, 20GT37, KME20H2590, KME20L0690, KME22D0945, KME22E1145, KME22G2935, KME22J0819, KME22J2900
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated