Arrow International Inc recalls Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product…

Recall date

May 17, 2019

Source

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

Recall number

Z-0053-2020

FDA classification

Class II

Brand / firm

Arrow International Inc

Sold / distributed

US Nationwide Distribution

Why it was recalled

Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (GA) values in a reversed manner.

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

What was recalled

Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access