FDA recall Z-1850-2023

TELEFLEX LLC · Class I · device

Product

Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504575

Reason for recall

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Distribution

US Nationwide distribution including Puerto Rico.

Key facts

Status
Ongoing
Initiation date
2023-05-25
Report date
2023-07-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Morrisville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1850-2023