Cook Inc. recalls Pressure Monitoring Tray, C-PMSY, G02854

Recall date

April 30, 2020

Source

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

Recall number

Z-2204-2020

FDA classification

Class II

Brand / firm

Cook Inc.

Sold / distributed

Worldwide distribution including distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Washington DC, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Min…

Why it was recalled

The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion.

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

What was recalled

Pressure Monitoring Tray, C-PMSY, G02854