Arrow International Inc recalls ARROW Epidural Needle Component (product number AN-05501). Epidural needles permit access to the epidural space and are…

Recall date

January 5, 2015

Source

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

Recall number

Z-1080-2015

FDA classification

Class II

Brand / firm

Arrow International Inc

Sold / distributed

Distribution US Nationwide, Canada and Mexico.

Why it was recalled

The product labeling does not specify the 5 year shelf life of the product.

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

What was recalled

ARROW Epidural Needle Component (product number AN-05501). Epidural needles permit access to the epidural space and are used as a conduit for epidural catheter placement.