Arrow International Inc recalls Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D02…

Recall date

June 2, 2016

Source

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

Recall number

Z-2201-2016

FDA classification

Class II

Brand / firm

Arrow International Inc

Sold / distributed

US distribution in the states of TN and KY.

Why it was recalled

Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits.

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

What was recalled

Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.