Teleflex Medical Europe Ltd recalls Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 Product Usage: for use in respira…

Recall date

March 27, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1403-2018

FDA classification

Class II

Brand / firm

Teleflex Medical Europe Ltd

Sold / distributed

US Nationwide in the states of AU, CA, NZ

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.