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Medtronic Perfusion Systems recalls BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO CAL(R) (unit) is a thermal trans
Recalled March 14, 2018 · FDA recall Z-0900-2018 · Medtronic Perfusion Systems
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. · FDA Class II
Units
1980 units
Sold at
Worldwide Distribution
Description
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.
Product
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.
Manufacturer(s)
Medtronic Perfusion Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →