Power Injectable CT Port insertion kits — Class II medical device recall Z-1184-2021
Ongoing recall by Medical Components, Inc dba MedComp, reported 2021-03-17, distributed nationwide. The 5F Dignity CT Port kits were packaged with the incorrect size port. The kits include a 6.6F port instead o
| Recall number | Z-1184-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medical Components, Inc dba MedComp, Harleysville, PA, United States |
| Recall initiated | 2021-01-13 |
| Classified | 2021-03-08 |
| Reported by FDA | 2021-03-17 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00884908149753 |
| Lot numbers | MPCY660, MPDX180 |
| Model numbers | MRDP50AXS |
Product
Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.
Reason for recall
The 5F Dignity CT Port kits were packaged with the incorrect size port. The kits include a 6.6F port instead of the correct 5F port. The inability to connect the catheter lumen to the port stem because of the incorrect size may not be noted until well into the procedure, after the catheter lumen is placed in the vessel. An alternate port will need to be obtained prolonging the procedure. A prolonged insertion procedure increases any risk associated with a surgical procedure.
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-1184-2021. 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.