Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 23, 2014
Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431
Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo¿ Cardiovascular Procedure Kits
Terumo Cardiovascular Systems Corp recalled Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Nu… - a moderate-severity action.
Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Nu… was recalled by Terumo Cardiovascular Systems Corp in April 23, 2014. Reason: Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo¿ Cardiovascula…. Check the official notice for the remedy. Verify recall #Z-1465-2014 with the FDA Devices before acting.
The recall
Terumo Cardiovascular Systems Corp issued this moderate-severity FDA Devices recall-Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo¿ Cardiovascula….
- Moderate
- severity level
- 37 units
- affected scope
- Class II
- classification
- April 23, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1465-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1465-2014) was formally reported on April 23, 2014, with the manufacturer initiating the action on March 28, 2014. 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 37 units.
The documented reason for this recall is: Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo¿ Cardiovascular Procedure Kits Distribution data in the federal record shows the product reached: CA. 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
37 units
Related Recalls
6
3 from same agency
Product description
Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431
Reason for recall
Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo¿ Cardiovascular Procedure Kits
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1465-2014 |
| Date reported | April 23, 2014 |
| Date initiated | March 28, 2014 |
| Recalling firm | Terumo Cardiovascular Systems Corp |
| Firm location | Ashland, MA |
| Affected scope | 37 units |
| Distribution | CA |
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-1465-2014) 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 Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431. Recalled by Terumo Cardiovascular Systems Corp. Units affected: 37 units.
Why was this product recalled? ▼
Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo¿ Cardiovascular Procedure Kits
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 23, 2014. Severity: Moderate. Recall number: Z-1465-2014.
Where was the recalled product distributed? ▼
Distribution: CA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1465-2014) 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 23, 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.