BIO CAL Temperature Controller recalled over fire hazard

Recall date

February 8, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Medtronic Perfusion Systems recalls BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO CAL(R) (unit) is a thermal transfer…

Recall number

Z-0900-2018

FDA classification

Class II

Brand / firm

Medtronic Perfusion Systems

Sold / distributed

Worldwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.