Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 4, 2012
MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power Injectable Implantable Infusion Port insertion kit.
Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low Profile Pro-Fuse CT Port. The kit contains an 8F Midsize Dignity CT Po…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medical Components, Inc dba MedComp recalled MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(… - a moderate-severity action.
MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(… was recalled by Medical Components, Inc dba MedComp in July 4, 2012. Reason: Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low P…. Check the official notice for the remedy. Verify recall #Z-1868-2012 with the FDA Devices before acting.
The recall
Medical Components, Inc dba MedComp issued this moderate-severity FDA Devices recall-Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low P….
- Moderate
- severity level
- 30 units
- affected scope
- Class II
- classification
- July 4, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1868-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1868-2012) was formally reported on July 4, 2012, with the manufacturer initiating the action on April 2, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Medical Components, Inc dba MedComp is listed as the recalling firm, operating out of Harleysville, PA. Federal records list the affected scope as 30.
The documented reason for this recall is: Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low Profile Pro-Fuse CT Port. The kit contains an 8F Midsize Dignity CT Port. Distribution data in the federal record shows the product reached: Worldwide Distribution-USA (nationwide) including the states of GA and WA and the countries of Ireland and Turkey.. 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
30
Related Recalls
6
3 from same agency
Product description
MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power Injectable Implantable Infusion Port insertion kit.
Reason for recall
Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low Profile Pro-Fuse CT Port. The kit contains an 8F Midsize Dignity CT Port.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1868-2012 |
| Date reported | July 4, 2012 |
| Date initiated | April 2, 2012 |
| Recalling firm | Medical Components, Inc dba MedComp |
| Firm location | Harleysville, PA |
| Affected scope | 30 |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of GA and WA and the countries of Ireland and Turkey. |
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-1868-2012) 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? ▼
MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power Injectable Implantable Infusion Port insertion kit.. Recalled by Medical Components, Inc dba MedComp. Units affected: 30.
Why was this product recalled? ▼
Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low Profile Pro-Fuse CT Port. The kit contains an 8F Midsize Dignity CT Port.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 4, 2012. Severity: Moderate. Recall number: Z-1868-2012.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution-USA (nationwide) including the states of GA and WA and the countries of Ireland and Turkey..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1868-2012) 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 July 4, 2012. 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.