Elcam Medical, Inc. recalls Elcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gxl:w1/r rbls Product Usage: indicated for f…

Recall date

February 2, 2017

Source

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

Recall number

Z-1869-2017

FDA classification

Class II

Brand / firm

Elcam Medical, Inc.

Sold / distributed

U.S Nationwide Distribution

Why it was recalled

The stopcock was found to have punctures.

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

What was recalled

Elcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gxl:w1/r rbls Product Usage: indicated for fluid flow directional control and for providing access ports for administration of intravenous solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.