HEMASHIELD Knitted Double Velour Cardiovascular Fabric recalled over labeling errors

Recall date

January 3, 2018

Source

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

Official notice title

GETINGE US SALES LLC recalls HEMASHIELD Knitted Double Velour Cardiovascular Fabric

Recall number

Z-1172-2018

FDA classification

Class II

Brand / firm

GETINGE US SALES LLC

Sold / distributed

FL

Why it was recalled

A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual product inside the box is 2.5 cm (width) x 15 cm (length).

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

What was recalled

HEMASHIELD Knitted Double Velour Cardiovascular Fabric