Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 6, 2016
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
Specific CDI¿ Blood Parameter Monitoring System 500 devices are being voluntarily recalled because the BPM Sensor Head Assemblys Thermistor, which provides the blood temperature …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Terumo Cardiovascular Systems Corporation recalled CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monit… - a moderate-severity action.
CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monit… was recalled by Terumo Cardiovascular Systems Corporation in April 6, 2016. Reason: Specific CDI¿ Blood Parameter Monitoring System 500 devices are being voluntarily recalled because the BPM Se…. Check the official notice for the remedy. Verify recall #Z-1250-2016 with the FDA Devices before acting.
The recall
Terumo Cardiovascular Systems Corporation issued this moderate-severity FDA Devices recall-Specific CDI¿ Blood Parameter Monitoring System 500 devices are being voluntarily recalled because the BPM Se….
- Moderate
- severity level
- 222 units
- affected scope
- Class II
- classification
- April 6, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1250-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1250-2016) was formally reported on April 6, 2016, with the manufacturer initiating the action on March 14, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Terumo Cardiovascular Systems Corporation is listed as the recalling firm, operating out of Ann Arbor, MI. Federal records list the affected scope as 222.
The documented reason for this recall is: 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 v… Distribution data in the federal record shows the product reached: Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Belgium, Canada, Japan , Singapore and United Arab Emirates.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
222
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1250-2016 |
| Date reported | April 6, 2016 |
| Date initiated | March 14, 2016 |
| Recalling firm | Terumo Cardiovascular Systems Corporation |
| Firm location | Ann Arbor, MI |
| Affected scope | 222 |
| Distribution | Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Belgium, Canada, Japan , Singapore and United Arab Emirates. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1250-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was 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.. Recalled by Terumo Cardiovascular Systems Corporation. Units affected: 222.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 6, 2016. Severity: Moderate. Recall number: Z-1250-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Belgium, Canada, Japan , Singapore and United Arab Emirates..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1250-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 6, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.