Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported March 2, 2016
CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: Heart/Lung Perfusion Pack is either a customized tubing pack built to user specifications or a stock tubing pack, designed for use during surgery requiring cardiopulmonary bypass. It is not designed for long-term use (greater than six hours). Perfusion Packs labeled as SMART¿ contain components that have an additive to improve blood compatibility. Non-SMART pack
The CDI System 500 monitor displays the "H/S DISCONNECT AT CUVETTE" error message when the CDI HIS Cuvette does not make a proper connection with the CDI H/S Probe. When this occu…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Sorin Group USA, Inc. recalled CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack… - a low-severity action.
CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack… was recalled by Sorin Group USA, Inc. in March 2, 2016. Reason: The CDI System 500 monitor displays the "H/S DISCONNECT AT CUVETTE" error message when the CDI HIS Cuvette do…. Check the official notice for the remedy. Verify recall #Z-1018-2016 with the FDA Devices before acting.
The recall
Sorin Group USA, Inc. issued this low-severity FDA Devices recall-The CDI System 500 monitor displays the "H/S DISCONNECT AT CUVETTE" error message when the CDI HIS Cuvette do….
- Low
- severity level
- 7K units
- affected scope
- Class III
- classification
- March 2, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1018-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1018-2016) was formally reported on March 2, 2016, with the manufacturer initiating the action on January 19, 2016. It is classified under Low severity (Class III), with a current status of Terminated. Sorin Group USA, Inc. is listed as the recalling firm, operating out of Arvada, CO. Federal records list the affected scope as 6859.
The documented reason for this recall is: The CDI System 500 monitor displays the "H/S DISCONNECT AT CUVETTE" error message when the CDI HIS Cuvette does not make a proper connection with the CDI H/S Probe. When this occurs, blood parameter values for HCT, Hgb … Distribution data in the federal record shows the product reached: US Nationwide Distribution and Canada.. 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
6859
Related Recalls
6
3 from same agency
Product description
CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: Heart/Lung Perfusion Pack is either a customized tubing pack built to user specifications or a stock tubing pack, designed for use during surgery requiring cardiopulmonary bypass. It is not designed for long-term use (greater than six hours). Perfusion Packs labeled as SMART¿ contain components that have an additive to improve blood compatibility. Non-SMART packs may contain some SMART tubing and/or connectors depending on the customer requirements.
Reason for recall
The CDI System 500 monitor displays the "H/S DISCONNECT AT CUVETTE" error message when the CDI HIS Cuvette does not make a proper connection with the CDI H/S Probe. When this occurs, blood parameter values for HCT, Hgb and S02 do not display.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1018-2016 |
| Date reported | March 2, 2016 |
| Date initiated | January 19, 2016 |
| Recalling firm | Sorin Group USA, Inc. |
| Firm location | Arvada, CO |
| Affected scope | 6859 |
| Distribution | US Nationwide Distribution and Canada. |
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-1018-2016) 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 H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: Heart/Lung Perfusion Pack is either a customized tubing pack built to user specifications or a stock tubing pack, designed for use during surgery requiring cardiopulmonary bypass. It is not designed for long-term use (greater than six hours). Perfusion Packs labeled as SMART¿ contain components that have an additive to improve blood compatibility. Non-SMART packs may contain some SMART tubing and/or connectors depending on the customer requirements.. Recalled by Sorin Group USA, Inc.. Units affected: 6859.
Why was this product recalled? ▼
The CDI System 500 monitor displays the "H/S DISCONNECT AT CUVETTE" error message when the CDI HIS Cuvette does not make a proper connection with the CDI H/S Probe. When this occurs, blood parameter values for HCT, Hgb and S02 do not display.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 2, 2016. Severity: Low. Recall number: Z-1018-2016.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution and Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1018-2016) 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 March 2, 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.