CIVCO Shoulder Retractors recalled over sterility concerns

Recall date

August 19, 2015

Source

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

Official notice title

Med Tec Inc recalls CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX. For use in patient p…

Recall number

Z-2763-2015

FDA classification

Class II

Brand / firm

Med Tec Inc

Sold / distributed

Worldwide Distribution - US including NE, SC, and KS. Foreign distribution was made to Australia, China, Venezuela, Spain, Turkey, and Hong Kong

Why it was recalled

The wrist straps used for positioning the patient are too long

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

What was recalled

CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX. For use in patient positioning. The grips are used for pulling down the shoulders during radiotherapy simulation and treatment sessions where opposed lateral fields are used in the neck area.