FDA recall Z-1403-2018

Product

Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 Product Usage: for use in respiratory and anesthesia circuits to connect two or more components of a breathing system.

Reason for recall

These one-way valves may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the patient.

Distribution

US Nationwide in the states of AU, CA, NZ

Key facts

Status

Terminated

Initiation date

2018-03-27

Report date

2018-04-25

Termination date

2021-05-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Athlone, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1403-2018