Maquet Cardiovascular Us Sales, Llc recalls Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039

Recall date

February 20, 2020

Source

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

Recall number

Z-1603-2020

FDA classification

Class II

Brand / firm

Maquet Cardiovascular Us Sales, Llc

Sold / distributed

Domestic distribution only to the following states: AL AZ CA CT FL GA IL MA MI NC NH NM NY OH OK TN TX VA

Why it was recalled

A lot of Avalon Elite Vascular Access Kits (VAK) are being recalled due to a material mix-up with the needle portion of the kit; 81 of 255 kits were assembled with an incorrect Arterial Access Needle instead of a Multi-Purpose Procedure Needle.

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

What was recalled

Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039