PlainRecalls
FDA Devices Critical Class I Ongoing

Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504590

Reported: July 5, 2023 Initiated: May 25, 2023 #Z-1853-2023

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.

Details

Recalling Firm
TELEFLEX LLC
Units Affected
13710 units
Distribution
US Nationwide distribution including Puerto Rico.
Location
Morrisville, NC

Frequently Asked Questions

What product was recalled?
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504590. Recalled by TELEFLEX LLC. Units affected: 13710 units.
Why was this product recalled?
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 5, 2023. Severity: Critical. Recall number: Z-1853-2023.