Recall Z-0900-2018 ยท DWJ System, Thermal Regulating
Medtronic Perfusion Systems
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.
| Date | Feb 8, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | Medtronic sent an Urgent Medical Device Recall dated February 2018 via UPS 2-Day.to their customers. The letter identified the affected product, problem and actions to be taken. Medtronic recommended that the affected device no longer be used for clinical procedures. Customers are asked to dispose of any devices in their possession per their normal equipment obsolescence procedures. Customer are also instructed to not resell any devices for clinical use. For questions contact your Medtronic Sales Representative. |
| Quantity | 1980 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K894980 | BIO-CAL 370 HEATER/COOLER Bio Medicus, Inc., Nov 2, 1989 |