CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The…
Medical device recall Z-1250-2016. Published in FDA’s Enforcement Report on Apr 6, 2016.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 6, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 222 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Specific CDI¿ Blood Parameter Monitoring System 500 devices are being voluntarily recalled because the BPM Sensor Head Assemblys Thermistor, which provides the blood temperature value that results in accurate display values on the monitor, does not meet specification. This may cause inaccurate temperature measurement and inaccurate analyte display values on the CDI System 500 monitor. Terumo Cardiovascular Systems (Terumo CVS) received complaints of inaccurate temperature measurements for specific devices distributed since November 5, 2015. These include both new production devices and recently serviced devices. POTENTIAL HAZARD There have been no reported illnesses or injuries as a result of this issue. A user who is not aware that the CDI System 500 is displaying inaccurate temperature values may not manage patient temperature appropriately. Using inaccurate information to manage warming and cooling strategies for a procedure could result in prolonged time on bypass. It could also lead to unnecessarily aggressive temperature management, resulting in excessive hyper or hypothermia, with potential neurologic and organ dysfunction, or increased blood component damage. Inaccurate temperature measurement could also cause inaccurate measurements of other BPM values including potassium (K+), pO2, pCO2, and pH. The greater the temperature inaccuracy, the greater the degree of inaccuracy of these other BPM values due to the dependence of their algorithms on temperature for the calculations. Inaccurate measurement of these values could result in inappropriate patient management strategies being employed to address them with the potential to result in moderate patient injury.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37 C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.
222, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
CDI 500 MONITOR WITH ART/HS (500AHCT item number 137613) SN #’s: 1190 1310 1346 1594 1647 1687 1693 1706 1769 1866 2028 2220 2242 2294 2311 2394 2460 2485 2506 2519 2644 2729 2776 2780 2821 2827 2858 2898 2900 3002 3092 3163 3184 3325 3513…
Every code shown here, 1,993 characters
CDI 500 MONITOR WITH ART/HS (500AHCT item number 137613) SN #’s: 1190 1310 1346 1594 1647 1687 1693 1706 1769 1866 2028 2220 2242 2294 2311 2394 2460 2485 2506 2519 2644 2729 2776 2780 2821 2827 2858 2898 2900 3002 3092 3163 3184 3325 3513 3805 3808 3818 3823 3842 4061 4102 4109 5173 5264 5806 8003 8006 8007 8008 8009 8010 8011 8012 8013 8016 8018 8020 8026 8031 8034 8035 8040 8056 8060 500AHCT MTR - CON LOANER (500AHCTCL item number 411150) SN #’s: 1035 1060 1178 1198 1199 1228 1280 1325 1364 1535 1540 1545 1553 1557 1615 1689 1695 1743 1759 1850 1862 1942 1949 1988 2014 2147 2336 2359 2360 2557 2563 2609 3097 3337 3431 3433 3527 4059 4324 4327 5609 5698 5700 5701 5809 5820 5889 5894 5945 5991 7028 7029 7030 7034 7038 7061 500AHCT MONITOR - LOANER (500AHCTL item number 418538) SN #’s: 1283 2209 5546 CDI 500 MONITOR WITH ART/VEN (500AV item number 137621) SN #’s: 3132 6004 CDI 500 MONITOR W/ ART/VEN/HS (500AVHCT item number 137630) SN #’s: 1304 1405 1905 2105 2224 2495 2580 2633 2867 3332 3404 4224 5076 5096 8000 8002 8023 500AVHCT MTR - CON LOANER (500AVHCTCL item number 411168) SN #’s: 1036 1043 1046 1149 1151 1152 1264 1353 1354 1381 1389 1393 1624 1954 2074 2126 6016 6041 6042 6046 500AVHCT MONITOR-LOANER (500AVHCTL item number 372200) SN #’s: 1015 1038 1466 2035 7081 500AVHCT MONITOR - TRIAL (500AVHCTTK item number 476543) SN #’s: 1953 3425 500AV MONITOR - LOANER (500AVL item number 418520) SN #: 2023 Outside US. BPM SENSOR HEAD ASSY CDI 500 item number 145891 SN#’s: B019781 B019782 B019783 B019784 B019790 B019791 B019792 B019793 B019794 B019795 B019796 B019797 B019798 B019799 B019800 B019802 B019803 B019804 B019805 B019806 B019807 B019808 B019809 B019810 B019811 B019812 B019813 B019814 B019815 B019816 B019848 B019849 B019850 B019851 B019869 B019870 B019871 B019872 B019876 B019877 B019878 B019879 B019880 B019881 B019882 B019883 B019884 B019885 B019886 B019887 B019888 B019889 B019890 B019901 B019917 B019918 B019919 B019920 B019921 B019937 B019938 B019939…
FDA’s list runs to 3,185 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Belgium, Canada, Japan , Singapore and United Arab Emirates.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 14, 2016.
- FDA classified it on Mar 25, 2016.
- FDA’s Enforcement Report published it on Apr 6, 2016.
- FDA terminated it on Mar 28, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Terumo Cardiovascular Systems Corporation, of Ann Arbor, MI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,185 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.