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Medtronic Perfusion Systems recalls Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Veno
Recalled October 13, 2021 · FDA recall Z-0003-2022 · 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. · FDA Class II
Units
168 kits
Sold at
Worldwide distribution - US Nationwide distribution in the state of Massachusetts and the countries of Belgium, France, Germany Japan, Korea, Saudi Arabia, Spain, and Turkey.
Description
There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
Product
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Manufacturer(s)
Medtronic Perfusion Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →