Smiths Medical ASD Inc. recalls Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use onl…

Recall date

November 19, 2018

Source

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

Recall number

Z-0512-2019

FDA classification

Class II

Brand / firm

Smiths Medical ASD Inc.

Sold / distributed

The potentially affected products were shipped to customers in the US, Canada, and Mexico.

Why it was recalled

Certain lots of Medex" High Pressure Stopcocks were manufactured with an inner body defect that may result in a leak. Model Number - Lot Number MX4301L - 3538569 MX4331L - 3562377 & 3546826 MX4331R - 3546924

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

What was recalled

Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.