FDA-Device2021-10-13Class II
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Medtronic Perfusion Systems
Hazard
There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
Sold states
Worldwide distribution - US Nationwide distribution in the state of Massachusetts and the countries of Belgium, France, Germany Japan, Korea, Saudi Arabia, Spain, and Turkey.
Affected count
168 kits
Manufactured in
7611 Northland Dr N, Brooklyn Park, MN, United States
Products
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0003-2022Don't want to check this manually?
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