FDA-Device2018-02-14Class II
Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
Medtronic Perfusion Systems
Hazard
Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve.
Sold states
DE, IA, CA and Japan
Affected count
2914 units
Manufactured in
7611 Northland Dr N, N/A, Brooklyn Park, MN, United States
Products
Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0535-2018Don't want to check this manually?
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