Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 12, 2014
Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4: I ratio. Includes a Conducer Heat Exchanger and a MP4 Temperature & Pressure Module. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activ
Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Terumo Cardiovascular Systems Corp recalled Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 … - a moderate-severity action.
Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 … was recalled by Terumo Cardiovascular Systems Corp in November 12, 2014. Reason: Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised…. Check the official notice for the remedy. Verify recall #Z-0160-2015 with the FDA Devices before acting.
The recall
Terumo Cardiovascular Systems Corp issued this moderate-severity FDA Devices recall-Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised….
- Moderate
- severity level
- Class II
- classification
- November 12, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0160-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0160-2015) was formally reported on November 12, 2014, with the manufacturer initiating the action on March 1, 2011. It is classified under Moderate severity (Class II), with a current status of Terminated. Terumo Cardiovascular Systems Corp is listed as the recalling firm, operating out of Ashland, MA. Federal records list the affected scope as Catalog: 16579 ; Catalog 6375: 3256 units.
The documented reason for this recall is: Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line Distribution data in the federal record shows the product reached: Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.. 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
Catalog: 16579 ; Catalog 6375: 3256 units
Related Recalls
6
3 from same agency
Product description
Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4: I ratio. Includes a Conducer Heat Exchanger and a MP4 Temperature & Pressure Module. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activity.
Reason for recall
Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0160-2015 |
| Date reported | November 12, 2014 |
| Date initiated | March 1, 2011 |
| Recalling firm | Terumo Cardiovascular Systems Corp |
| Firm location | Ashland, MA |
| Affected scope | Catalog: 16579 ; Catalog 6375: 3256 units |
| Distribution | Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand. |
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-0160-2015) 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? ▼
Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4: I ratio. Includes a Conducer Heat Exchanger and a MP4 Temperature & Pressure Module. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activity.. Recalled by Terumo Cardiovascular Systems Corp. Units affected: Catalog: 16579 ; Catalog 6375: 3256 units.
Why was this product recalled? ▼
Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 12, 2014. Severity: Moderate. Recall number: Z-0160-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0160-2015) 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 November 12, 2014. 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.