FDA-Device2020-04-08Class II
Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
Maquet Cardiovascular Us Sales, Llc
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.
Sold states
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
Affected count
255
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1603-2020Don't want to check this manually?
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