FDA-Device2018-03-14Class II
BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO CAL(R) (unit) is a thermal transfer module designed to control patient blood temperature during cardiopulmonary bypass procedures when heating or cooling of the blood is desired.
Hazard
Medtronic has been unable to develop a cleaning protocol to satisfy current industry concerns and expectations. As a result, an updated cleaning protocol will not be developed by Medtronic and it has been determined that the best course of action is to request BIO CAL users to discontinue use and dispose of BIO CAL devices.
Sold states
Worldwide Distribution
Affected count
1980 units
Manufactured in
7611 Northland Dr N, N/A, Brooklyn Park, MN, United States
Products
BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO CAL(R) (unit) is a thermal transfer module designed to control patient blood temperature during cardiopulmonary bypass procedures when heating or cooling of the blood is desired.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0900-2018More Medtronic Perfusion Systems recalls
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