Medical device recalls Moderate risk

Arrow International Inc recalls Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product Code:AK-42854-P1A - Product Usage: The Arro…

Recall date
August 6, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2556-2019
FDA classification
Class II
Brand / firm
Arrow International Inc
Sold / distributed
US Nationwide distribution.

Why it was recalled

Products may contain the incorrect banner card within the kit

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 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product Code:AK-42854-P1A - Product Usage: The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins.

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