Arrow International Inc recalls Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Catheter Product Code: AH-11802 (OUS) GTN: 00801…

Recall date

January 10, 2019

Source

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

Recall number

Z-1118-2019

FDA classification

Class II

Brand / firm

Arrow International Inc

Sold / distributed

FL, NC

Why it was recalled

The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct

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¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132