Z-0604-2012

CDI 101 Hematocrit/Oxygen Saturation Monitoring System. The CDI 101 Hematocrit/Oxygen Saturation Monitoring...

Name: Z-0604-2012 CDI 101 Hematocrit/Oxygen Saturation Monitoring System. The CDI 101 Hematocrit/Oxygen Saturation Monitoring...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2011-12-07
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2011-12-07 / Terminated

FDA source

Terumo Cardiovascular Systems Corporation began a recall of CDI 101 Hematocrit/Oxygen Saturation Monitoring System. The CDI 101 Hematocrit/Oxygen Saturation Monitoring System is intended for use during cardiopulmonary... on 2011-12-07. The reason FDA records is "Terumo is recalling the CDI 101 Hematocrit/Oxygen Saturation Monitoring System because they have not yet submitted a 510(k) to FDA to market the device". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0604-2012
Status: Terminated
Initiated: 2011-12-07
Posted: 2012-01-11
Terminated: 2013-08-30
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: CDI 101 Hematocrit/Oxygen Saturation Monitoring System. The CDI 101 Hematocrit/Oxygen Saturation Monitoring System is intended for use during cardiopulmonary bypass procedures where continuous monitoring of the blood's oxygen saturation, hematocrit and hemoglobin levels is needed.
Product code: DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Reason for recall: Terumo is recalling the CDI 101 Hematocrit/Oxygen Saturation Monitoring System because they have not yet submitted a 510(k) to FDA to market the device.
FDA root cause: No Marketing Application
Action: 12/7/11 & 12/8/11 All consignees received a "Transition and Notification Guide" dated 12/6/11 and a "URGENT MEDICAL DEVICE REMOVAL" letter dated 12/4/11, which will inform them of the removal of the CD l 101 and provide the user with various options. Terumo will remove CD l 101 units from the US market over the next 18 months.
Quantity in commerce: 366
Distribution: Nationwide Distribution - Including the states of: NV, MO, SC, WA, MI, FL, GA, NY, CT, IL, VA, NY, TN, IN, HI, TX, AL, OH, MD, AZ, CA, KS, MD, PA, and NM.
Product codes and lots: Catalog number :101; Serial Numbers: 1070, 1071, 1076, 1077, 1080, 1083, 1104, 1107, 1108, 1115-1117, 1124, 1127, 1128, 1132-1134, 1136, 1137, 1139-1144, 1148, 1151, 1152, 1154-1156, 1160-1162, 1166, 1168-1173, 1182,1185,1186,1190,1192, 1193, 1195, 1239-1241, 1243-1245, 1247, 1249-1257,1261, 1264-1266, 1268-1277,1279, 1280, 1282-1289, 1297,1299-1301, 1306-1311, 1313-1318, 1321-1324, 1337-1339, 1350-1355, 1357-1363, 1365-1377, 1382, 1386, 1406-1409, 1411, 1413,1414, 1417-1422, 1428-1436, 1440, 1441, 1443-1447, 1450-1453, 1455-1458, 1460, 1463, 1469-1482, 1484, 1486, 1488, 1492,1503-1511 ,1513, 1515-1520, 1532-1534, 1537, 1540, 1542, 1543, 1547, 1548, 1550, 1551, 1555, 1560-1563, 1568-1574, 1578, 1579, 1585-1596, 1598, 1614, 1615, 1617-1622, 1625-1629, 1632-1647, 1653, 1655, 1660, 1666, 1667, 1669-1676, 1679, 1681, 1682, 1690, 1693, 1694, 1696, 1699, 1705-1709, 1713, 1714, 1726, 1729-1734,1738, 1745-1750,1752-1756,1760, 1764-1768, 1771, 1773-1777,1785,1787,1788,1790-1794,1797-1799,1801-1808,1816,1818-1821, 1823, 1826, and 1839.

Product code DRY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)