Class II — Medical Components, Inc dba MedComp
| Recalling firm | Medical Components Inc |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 30 |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of GA and WA and the countries of Ireland and Turkey. |
| Initiated | 2012-04-02 |
| Classified | 2012-06-26 |
| Terminated | 2013-05-20 |
| Recall number | Z-1868-2012 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Medical Components, Inc dba MedComp (Z-1868-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62238/
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