Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 30, 2015
Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for
Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Terumo Cardiovascular Systems Corp recalled Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Te… - a moderate-severity action.
Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Te… was recalled by Terumo Cardiovascular Systems Corp in September 30, 2015. Reason: Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcen…. Check the official notice for the remedy. Verify recall #Z-2792-2015 with the FDA Devices before acting.
The recall
Terumo Cardiovascular Systems Corp issued this moderate-severity FDA Devices recall-Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcen….
- Moderate
- severity level
- Class II
- classification
- September 30, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2792-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2792-2015) was formally reported on September 30, 2015, with the manufacturer initiating the action on August 24, 2015. 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 17 kits.
The documented reason for this recall is: Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators Distribution data in the federal record shows the product reached: Nationwide Distribution including CA, CT , FL , WI.. 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
17 kits
Related Recalls
6
3 from same agency
Product description
Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed
Reason for recall
Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2792-2015 |
| Date reported | September 30, 2015 |
| Date initiated | August 24, 2015 |
| Recalling firm | Terumo Cardiovascular Systems Corp |
| Firm location | Ashland, MA |
| Affected scope | 17 kits |
| Distribution | Nationwide Distribution including CA, CT , FL , WI. |
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-2792-2015) 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 Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed. Recalled by Terumo Cardiovascular Systems Corp. Units affected: 17 kits.
Why was this product recalled? ▼
Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 30, 2015. Severity: Moderate. Recall number: Z-2792-2015.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution including CA, CT , FL , WI..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2792-2015) 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 September 30, 2015. 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.