FDAFebruary 8, 2018device
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 recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
medtronic perfusion systemsmedtronicmedtronic perfusion
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAOctopus Evolution Tissue Stabilizer, Model TS20002026-05-12
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