Elcam Medical, Inc. recalls Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid administration. Man…

Recall date

July 19, 2015

Source

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

Recall number

Z-2749-2015

FDA classification

Class II

Brand / firm

Elcam Medical, Inc.

Sold / distributed

Texas, New Mexico and Pennsylvania

Why it was recalled

Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination.

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 Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid administration. Manufactured by: Elcam Medical ACAL, Israel; Distributed by: Elcam Medical Inc., USA. Sterile