MRCTT80041 MedComp 8F Plastic Pro-Fuse — Class II medical device recall Z-1868-2012
Terminated recall by Medical Components, Inc dba MedComp, reported 2012-07-04, distributed nationwide. Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low Pro
| Recall number | Z-1868-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medical Components, Inc dba MedComp, Harleysville, PA, United States |
| Recall initiated | 2012-04-02 |
| Classified | 2012-06-26 |
| Reported by FDA | 2012-07-04 |
| Terminated | 2013-05-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | IE, TR |
| Quantity | 30 |
| Reason classes | labeling |
| Lot numbers | MDNK860 |
| Model numbers | MRCTT80041 |
| Expiration dates | 2015-02 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1868-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.