Recall Z-0900-2018— Medtronic Perfusion Systems
Class II · Terminated
Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2018-02-08, terminated 2020-08-06. It names one FDA 510(k) clearance: K894980. 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.. Reason: 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..
- Recalling firm
- Medtronic Perfusion Systems
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-02-08
- Terminated
- 2020-08-06
- Firm location
- Brooklyn Park, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.