Arrow International Inc recalls Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dre…

Recall date

January 9, 2015

Source

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

Recall number

Z-1030-2015

FDA classification

Class III

Brand / firm

Arrow International Inc

Sold / distributed

US (nationwide) and PR.

Why it was recalled

Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the incorrect size Biopatch Dressing. No risk to patients is anticipated.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing