Class 2 Device Recall BIO CAL(R) 370/370I Temperature Controller

• Date Initiated by Firm: February 08, 2018
• Create Date: March 06, 2018
• Recall Status: Terminated on August 06, 2020
• Recall Number: Z-0900-2018
• Recall Event ID: 79235
• 510(K)Number: K894980
• Product Classification: System, thermal regulating - Product Code DWJ
• 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.
• Code Information: (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 0775 AK0885 AK0996 AK1106 AK1217 AK1327 AK1438 AK1548 0113 0223 0334 0444 0555 0665 0776 AK0886 AK0997 AK1107 AK1218 AK1328 AK1439 AK1549 0114 0224 0335 0445 0556 0666 0777 AK0887 AK0998 AK1108 AK1219 AK1329 AK1440 AK1550 0115 0225 0336 0446 0557 0667 0778 AK0888 AK0999 AK1109 AK1220 AK1330 AK1441 AK1551 0116 0226 0337 0447 0558 0668 0779 AK0889 AK1000 AK1110 AK1221 AK1331 AK1442 AK1552 0117 0227 0338 0448 0559 0669 0780 AK0890 AK1001 AK1111 AK1222 AK1332 AK1443 AK1553 0118 0228 0339 0449 0560 0670 0781 AK0891 AK1002 AK1112 AK1223 AK1333 AK1444 AK1554 0119 0229 0340 0450 0561 0671 0782 AK0892 AK1003 AK1113 AK1224 AK1334 AK1445 AK1555 0120 0230 0341 0451 0562 0672 0783 AK0893 AK1004 AK1114 AK1225 AK1335 AK1446 AK1556 0121 0231 0342 0452 0563 0673 0784 AK0894 AK1005 AK1115 AK1226 AK1336 AK1447 AK1557 0122 0232 0343 0453 0564 0674 0785 AK0895 AK1006 AK1116 AK1227 AK1337 AK1448 AK1558 0123 0233 0344 0454 0565 0675 0786 AK0896 AK1007 AK1117 AK1228 AK1338 AK1449 AK1559 0124 0234 0345 0455 0566 0676 0787 AK0897 AK1008 AK1118 AK1229 AK1339 AK1450 AK1560 0125 0235 0346 0456 0567 0677 0788 AK0898 AK1009 AK1119 AK1230 AK1340 AK1451 AK1561 0126 0236 0347 0457 0568 0678 0789 AK0899 AK1010 AK1120 AK1231 AK1341 AK1452 AK1562 0127 0237 0348 0458 0569 0679 0790 AK0900 AK1011 AK1121 AK1232 AK1342 AK1453 AK1563 0128 0238 0349 0459 0570 0680 0791 AK0901 AK1012 AK1122 AK1233 AK1343 AK1454 AK1564 0129 0239 0350 0460 0571 0681 0792 AK0902 AK1013 AK1123 AK1234 AK1344 AK1455 AK1565 0130 0240 0351 0461 0572 0682 0793 AK0903 AK1014 AK1124 AK1235 AK1345 AK1456 AK1566 0131 0241 0352 0462 0573 0683 0794 AK0904 AK1015 AK1125 AK1236 AK1346 AK1457 AK1567 0132 0242 0353 0463 0574 0684 0795 AK0905 AK1016 AK1126 AK1237 AK1347 AK1458 AK1568 0133 0243 0354 0464 0575 0685 0796 AK0906 AK1017 AK1127 AK1238 AK1348 AK1459 AK1569 0134 0244 0355 0465 0576 0686 0797 AK0907 AK1018 AK1128 AK1239 AK1349 AK1460 AK1570 0135 0245 0356 0466 0577 0687 0798 AK0908 AK1019 AK1129 AK1240 AK1350 AK1461 AK1571 0136 0246 0357 0467 0578 0688 0799 AK0909 AK1020 AK1130 AK1241 AK1351 AK1462 AK1572 0137 0247 0358 0468 0579 0689 0800 AK0910 AK1021 AK1131 AK1242 AK1352 AK1463 AK1573 0138 0248 0359 0469 0580 0690 0801 AK0911 AK1022 AK1132 AK1243 AK1353 AK1464 AK1574 0139 0249 0360 0470 0581 0691 0802 AK0912 AK1023 AK1133 AK1244 AK1354 AK1465 AK1575 0140 0250 0361 0471 0582 0692 0803 AK0913 AK1024 AK1134 AK1245 AK1355 AK1466 AK1576 0141 0251 0362 0472 0583 0693 0804 AK0914 AK1025 AK1135 AK1246 AK1356 AK1467 AK1577 0142 0252 0363 0473 0584 0694 0805 AK0915 AK1026 AK1136 AK1247 AK1357 AK1468 AK1578 0143 0253 0364 0474 0585 0695 0806 AK0916 AK1027 AK1137 AK1248 AK1358 AK1469 AK1579 0144 0254 0365 0475 0586 0696 0807 AK0917 AK1028 AK1138 AK1249 AK1359 AK1470 AK1580 0145 0255 0366 0476 0587 0697 0808 AK0918 AK1029 AK1139 AK1250 AK1360 AK1471 AK1581 0146 0256 0367 0477 0588 0698 0809 AK0919 AK1030 AK1140 AK1251 AK1361 AK1472 AK1582 0147 0257 0368 0478 0589 0699 0810 AK0920 AK1031 AK1141 AK1252 AK1362 AK1473 AK1583 0148 0258 0369 0479 0590 0700 0811 AK0921 AK1032 AK1142 AK1253 AK1363 AK1474 AK1584 0149 0259 0370 0480 0591 0701 0812 AK0922 AK1033 AK1143 AK1254 AK1364 AK1475 AK1585 0150 0260 0371 0481 0592 0702 0813 AK0923 AK1034 AK1144 AK1255 AK1365 AK1476 AK1586 0151 0261 0372 0482 0593 0703 0814 AK0924 AK1035 AK1145 AK1256 AK1366 AK1477 AK1587 0152 0262 0373 0483 0594 0704 0815 AK0925 AK1036 AK1146 AK1257 AK1367 AK1478 AK1588 0153 0263 0374 0484 0595 0705 0816 AK0926 AK1037 AK1147 AK1258 AK1368 AK1479 AK1589 0154 0264 0375 0485 0596 0706 0817 AK0927 AK1038 AK1148 AK1259 AK1369 AK1480 AK1590 0155 0265 0376 0486 0597 0707 0818 AK0928 AK1039 AK1149 AK1260 AK1370 AK1481 AK1591 0156 0266 0377 0487 0598 0708 0819 AK0929 AK1040 AK1150 AK1261 AK1371 AK1482 AK1592 0157 0267 0378 0488 0599 0709 0820 AK0930 AK1041 AK1151 AK1262 AK1372 AK1483 AK1593 0158 0268 0379 0489 0600 0710 AK0821 AK0931 AK1042 AK1152 AK1263 AK1373 AK1484 AK1594 0159 0269 0380 0490 0601 0711 AK0822 AK0932 AK1043 AK1153 AK1264 AK1374 AK1485 AK1595 0160 0270 0381 0491 0602 0712 AK0823 AK0933 AK1044 AK1154 AK1265 AK1375 AK1486 AK1596 0161 0271 0382 0492 0603 0713 AK0824 AK0934 AK1045 AK1155 AK1266 AK1376 AK1487 AK1597 0162 0272 0383 0493 0604 0714 AK0825 AK0935 AK1046 AK1156 AK1267 AK1377 AK1488 AK1598 0163 0273 0384 0494 0605 0715 AK0826 AK0936 AK1047 AK1157 AK1268 AK1378 AK1489 AK1599 0164 0274 0385 0495 0606 0716 AK0827 AK0937 AK1048 AK1158 AK1269 AK1379 AK1490 AK1600 0165 0275 0386 0496 0607 0717 AK0828 AK0938 AK1049 AK1159 AK1270 AK1380 AK1491 AK1601 0166 0276 0387 0497 0608 0718 AK0829 AK0939 AK1050 AK1160 AK1271 AK1381 AK1492 AK1602 0167 0277 0388 0498 0609 0719 AK0830 AK0940 AK1051 AK1161 AK1272 AK1382 AK1493 AK1603 0168 0278 0389 0499 0610 0720 AK0831 AK0941 AK1052 AK1162 AK1273 AK1383 AK1494 AK1604 0169 0279 0390 0500 0611 0721 AK0832 AK0942 AK1053 AK1163 AK1274 AK1384 AK1495 AK1605 0170 0280 0391 0501 0612 0722 AK0833 AK0943 AK1054 AK1164 AK1275 AK1385 AK1496 AK1606 0171 0281 0392 0502 0613 0723 AK0834 AK0944 AK1055 AK1165 AK1276 AK1386 AK1497 AK1607 0172 0282 0393 0503 0614 0724 AK0835 AK0945 AK1056 AK1166 AK1277 AK1387 AK1498 AK1608 0173 0283 0394 0504 0615 0725 AK0836 AK0946 AK1057 AK1167 AK1278 AK1388 AK1499 AK1609 0174 0284 0395 0505 0616 0726 AK0837 AK0947 AK1058 AK1168 AK1279 AK1389 AK1500 AK1610 0175 0285 0396 0506 0617 0727 AK0838 AK0948 AK1059 AK1169 AK1280 AK1390 AK1501 AK1611 0176 0286 0397 0507 0618 0728 AK0839 AK0949 AK1060 AK1170 AK1281 AK1391 AK1502 AK1612 0177 0287 0398 0508 0619 0729 AK0840 AK0950 AK1061 AK1171 AK1282 AK1392 AK1503 AK1613 0178 0288 0399 0509 0620 0730 AK0841 AK0951 AK1062 AK1172 AK1283 AK1393 AK1504 AK1614 0179 0289 0400 0510 0621 0731 AK0842 AK0952 AK1063 AK1173 AK1284 AK1394 AK1505 AK1615 0180 0290 0401 0511 0622 0732 AK0843 AK0953 AK1064 AK1174 AK1285 AK1395 AK1506 AK1616 0181 0291 0402 0512 0623 0733 AK0844 AK0954 AK1065 AK1175 AK1286 AK1396 AK1507 AK1617 0182 0292 0403 0513 0624 0734 AK0845 AK0955 AK1066 AK1176 AK1287 AK1397 AK1508 AK1618 0183 0293 0404 0514 0625 0735 AK0846 AK0956 AK1067 AK1177 AK1288 AK1398 AK1509 AK1619 0184 0294 0405 0515 0626 0736 AK0847 AK0957 AK1068 AK1178 AK1289 AK1399 AK1510 AK1620 0185 0295 0406 0516 0627 0737 AK0848 AK0958 AK1069 AK1179 AK1290 AK1400 AK1511 AK1621 0186 0296 0407 0517 0628 0738 AK0849 AK0959 AK1070 AK1180 AK1291 AK1401 AK1512 AK1622 0187 0297 0408 0518 0629 0739 AK0850 AK0960 AK1071 AK1181 AK1292 AK1402 AK1513 AK1623 0188 0298 0409 0519 0630 0740 AK0851 AK0961 AK1072 AK1182 AK1293 AK1403 AK1514 AK1624 0189 0299 0410 0520 0631 0741 AK0852 AK0962 AK1073 AK1183 AK1294 AK1404 AK1515 AK1625 0190 0300 0411 0521 0632 0742 AK0853 AK0963 AK1074 AK1184 AK1295 AK1405 AK1516 AK1626 0191 0301 0412 0522 0633 0743 AK0854 AK0964 AK1075 AK1185 AK1296 AK1406 AK1517 AK1627 0192 0302 0413 0523 0634 0744 AK0855 AK0965 AK1076 AK1186 AK1297 AK1407 AK1518 AK1628 0193 0303 0414 0524 0635 0745 AK0856 AK0966 AK1077 AK1187 AK1298 AK1408 AK1519 AK1629 0194 0304 0415 0525 0636 0746 AK0857 AK0967 AK1078 AK1188 AK1299 AK1409 AK1520 AK1630 0195 0305 0416 0526 0637 0747 AK0858 AK0968 AK1079 AK1189 AK1300 AK1410 AK1521 AK1631 0196 0306 0417 0527 0638 0748 AK0859 AK0969 AK1080 AK1190 AK1301 AK1411 AK1522 AK1632 0197 0307 0418 0528 0639 0749 AK0860 AK0970 AK1081 AK1191 AK1302 AK1412 AK1523 AK1633 0198 0308 0419 0529 0640 0750 AK0861 AK0971 AK1082 AK1192 AK1303 AK1413 AK1524 AK1634 0199 0309 0420 0530 0641 0751 AK0862 AK0972 AK1083 AK1193 AK1304 AK1414 AK1525 AK1635 0200 0310 0421 0531 0642 0752 AK0863 AK0973 AK1084 AK1194 AK1305 AK1415 AK1526 AK1636 0201 0311 0422 0532 0643 0753 AK0864 AK0974 AK1085 AK1195 AK1306 AK1416 AK1527 AK1637 0202 0312 0423 0533 0644 0754 AK0865 AK0975 AK1086 AK1196 AK1307 AK1417 AK1528 AK1638 0203 0313 0424 0534 0645 0755 AK0866 AK0976 AK1087 AK1197 AK1308 AK1418 AK1529 AK1639 0204 0314 0425 0535 0646 0756 AK0867 AK0977 AK1088 AK1198 AK1309 AK1419 AK1530 AK1640 0205 0315 0426 0536 0647 0757 AK0868 AK0978 AK1089 AK1199 AK1310 AK1420 AK1531 AK1641 0206 0316 0427 0537 0648 0758 AK0869 AK0979 AK1090 AK1200 AK1311 AK1421 AK1532 AK1642 0207 0317 0428 0538 0649 0759 AK0870 AK0980 AK1091 AK1201 AK1312 AK1422 AK1533 AK1643 0208 0318 0429 0539 0650 0760 AK0871 AK0981 AK1092 AK1202 AK1313 AK1423 AK1534 AK1644 0209 0319 0430 0540 0651 0761 AK0872 AK0982 AK1093 AK1203 AK1314 AK1424 AK1535 AK1645 0210 0320 0431 0541 0652 0762 AK0873 AK0983 AK1094 AK1204 AK1315 AK1425 AK1536 AK1646 n/a 0321 n/a 0542 n/a 0763 n/a AK0984 n/a AK1205 n/a AK1426 n/a AK1647 (b) Model 370I, Serial Numbers: I0101 I0140 I0179 I0218 I0257 I0296 I0335 I0374 I0413 I0452 I0491 I0530 I0569 I0608 I0102 I0141 I0180 I0219 I0258 I0297 I0336 I0375 I0414 I0453 I0492 I0531 I0570 I0609 I0103 I0142 I0181 I0220 I0259 I0298 I0337 I0376 I0415 I0454 I0493 I0532 I0571 I0610 I0104 I0143 I0182 I0221 I0260 I0299 I0338 I0377 I0416 I0455 I0494 I0533 I0572 I0611 I0105 I0144 I0183 I0222 I0261 I0300 I0339 I0378 I0417 I0456 I0495 I0534 I0573 I0612 I0106 I0145 I0184 I0223 I0262 I0301 I0340 I0379 I0418 I0457 I0496 I0535 I0574 I0613 I0107 I0146 I0185 I0224 I0263 I0302 I0341 I0380 I0419 I0458 I0497 I0536 I0575 I0614 I0108 I0147 I0186 I0225 I0264 I0303 I0342 I0381 I0420 I0459 I0498 I0537 I0576 I0615 I0109 I0148 I0187 I0226 I0265 I0304 I0343 I0382 I0421 I0460 I0499 I0538 I0577 I0616 I0110 I0149 I0188 I0227 I0266 I0305 I0344 I0383 I0422 I0461 I0500 I0539 I0578 I0617 I0111 I0150 I0189 I0228 I0267 I0306 I0345 I0384 I0423 I0462 I0501 I0540 I0579 I0618 I0112 I0151 I0190 I0229 I0268 I0307 I0346 I0385 I0424 I0463 I0502 I0541 I0580 I0619 I0113 I0152 I0191 I0230 I0269 I0308 I0347 I0386 I0425 I0464 I0503 I0542 I0581 I0620 I0114 I0153 I0192 I0231 I0270 I0309 I0348 I0387 I0426 I0465 I0504 I0543 I0582 I0621 I0115 I0154 I0193 I0232 I0271 I0310 I0349 I0388 I0427 I0466 I0505 I0544 I0583 I0622 I0116 I0155 I0194 I0233 I0272 I0311 I0350 I0389 I0428 I0467 I0506 I0545 I0584 I0623 I0117 I0156 I0195 I0234 I0273 I0312 I0351 I0390 I0429 I0468 I0507 I0546 I0585 I0624 I0118 I0157 I0196 I0235 I0274 I0313 I0352 I0391 I0430 I0469 I0508 I0547 I0586 I0625 I0119 I0158 I0197 I0236 I0275 I0314 I0353 I0392 I0431 I0470 I0509 I0548 I0587 I0626 I0120 I0159 I0198 I0237 I0276 I0315 I0354 I0393 I0432 I0471 I0510 I0549 I0588 I0627 I0121 I0160 I0199 I0238 I0277 I0316 I0355 I0394 I0433 I0472 I0511 I0550 I0589 I0628 I0122 I0161 I0200 I0239 I0278 I0317 I0356 I0395 I0434 I0473 I0512 I0551 I0590 I0629 I0123 I0162 I0201 I0240 I0279 I0318 I0357 I0396 I0435 I0474 I0513 I0552 I0591 I0630 I0124 I0163 I0202 I0241 I0280 I0319 I0358 I0397 I0436 I0475 I0514 I0553 I0592 I0631 I0125 I0164 I0203 I0242 I0281 I0320 I0359 I0398 I0437 I0476 I0515 I0554 I0593 I0632 I0126 I0165 I0204 I0243 I0282 I0321 I0360 I0399 I0438 I0477 I0516 I0555 I0594 I0633 I0127 I0166 I0205 I0244 I0283 I0322 I0361 I0400 I0439 I0478 I0517 I0556 I0595 I0634 I0128 I0167 I0206 I0245 I0284 I0323 I0362 I0401 I0440 I0479 I0518 I0557 I0596 I0635 I0129 I0168 I0207 I0246 I0285 I0324 I0363 I0402 I0441 I0480 I0519 I0558 I0597 I0636 I0130 I0169 I0208 I0247 I0286 I0325 I0364 I0403 I0442 I0481 I0520 I0559 I0598 I0637 I0131 I0170 I0209 I0248 I0287 I0326 I0365 I0404 I0443 I0482 I0521 I0560 I0599 I0638 I0132 I0171 I0210 I0249 I0288 I0327 I0366 I0405 I0444 I0483 I0522 I0561 I0600 I0639 I0133 I0172 I0211 I0250 I0289 I0328 I0367 I0406 I0445 I0484 I0523 I0562 I0601 I0640 I0134 I0173 I0212 I0251 I0290 I0329 I0368 I0407 I0446 I0485 I0524 I0563 I0602 I0641 I0135 I0174 I0213 I0252 I0291 I0330 I0369 I0408 I0447 I0486 I0525 I0564 I0603 I0136 I0175 I0214 I0253 I0292 I0331 I0370 I0409 I0448 I0487 I0526 I0565 I0604 I0137 I0176 I0215 I0254 I0293 I0332 I0371 I0410 I0449 I0488 I0527 I0566 I0605 I0138 I0177 I0216 I0255 I0294 I0333 I0372 I0411 I0450 I0489 I0528 I0567 I0606 I0139 I0178 I0217 I0256 I0295 I0334 I0373 I0412 I0451 I0490 I0529 I0568 I0607
• Recalling Firm/ Manufacturer: Medtronic Perfusion Systems; 7611 Northland Dr N; Brooklyn Park MN 55428-1088
• For Additional Information Contact: Joey Lomicky; 763-526-2494
• Manufacturer 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.
• FDA Determined 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 in Commerce: 1980 units
• Distribution: Worldwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DWJ and Original Applicant = BIO MEDICUS, INC.