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Maquet Cardiovascular Us Sales, Llc recalls Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
Recalled April 8, 2020 · FDA recall Z-1603-2020 · Maquet Cardiovascular Us Sales
Hazard
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. · FDA Class II
Units
255
Sold at
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
Description
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.
Product
Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
Manufacturer(s)
Maquet Cardiovascular Us Sales, Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →