FDA Device recall Z-0900-2018
BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO CAL(R) (unit) is a thermal transfer module designed to…
- FDA Device
- Class II
- terminated
- Published 2018-03-14
On 2018-03-14 the FDA classified a Class II recall of BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO CAL(R) (unit) is a thermal transfer module designed to… by Medtronic Perfusion Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0900-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-08 |
| Published | 2018-03-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Perfusion Systems |
| Distribution | n/a |
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.
Identifiers
| code_info | (a) Model 370, Serial Numbers: 0101 0211 0322 0432 0543 0653 0764 AK0874 AK0985 AK1095 AK1206 AK1316 AK1427 AK1537 01…(a) Model 370, Serial Numbers: 0101 0211 0322 0432 0543 0653 0764 AK0874 AK0985 AK1095 AK1206 AK1316 AK1427 AK1537 0102 0212 0323 0433 0544 0654 0765 AK0875 AK0986 AK1096 AK1207 AK1317 AK1428 AK1538 0103 0213 0324 0434 0545 0655 0766 AK0876 AK0987 AK1097 AK1208 AK1318 AK1429 AK1539 0104 0214 0325 0435 0546 0656 0767 AK0877 AK0988 AK1098 AK1209 AK1319 AK1430 AK1540 0105 0215 0326 0436 0547 0657 0768 AK0878 AK0989 AK1099 AK1210 AK1320 AK1431 AK1541 0106 0216 0327 0437 0548 0658 0769 AK0879 AK0990 AK1100 AK1211 AK1321 AK1432 AK1542 0107 0217 0328 0438 0549 0659 0770 AK0880 AK0991 AK1101 AK1212 AK1322 AK1433 AK1543 0108 0218 0329 0439 0550 0660 0771 AK0881 AK0992 AK1102 AK1213 AK1323 AK1434 AK1544 0109 0219 0330 0440 0551 0661 0772 AK0882 AK0993 AK1103 AK1214 AK1324 AK1435 AK1545 0110 0220 0331 0441 0552 0662 0773 AK0883 AK0994 AK1104 AK1215 AK1325 AK1436 AK1546 0111 0221 0332 0442 0553 0663 0774 AK0884 AK0995 AK1105 AK1216 AK1326 AK1437 AK1547 0112 0222 0333 0443 0554 0664 077 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0900-2018%22
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