6 — Class II medical device recall Z-0533-2018
Terminated recall by Medical Components, Inc dba MedComp, reported 2018-02-14. The kit was packaged with the incorrect introducer needle size. The label indicates the kit contains an 18G Ne
| Recall number | Z-0533-2018 |
|---|---|
| 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 | 2017-05-25 |
| Classified | 2018-02-06 |
| Reported by FDA | 2018-02-14 |
| Terminated | 2018-09-04 |
| Countries outside the US | AU, IL, JM |
| Quantity | 65 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00884908031157 |
| Lot numbers | MHGB030 |
| Model numbers | MRCTI66041 |
| Expiration dates | 2020-07-30 |
Product
6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 Product Usage: Indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a power injectable needle, the Power Injectable Implantable Infusion Port device is indicated for power injection of contrast media.
Reason for recall
The kit was packaged with the incorrect introducer needle size. The label indicates the kit contains an 18G Needle w/Echo Tip. The kits were packaged with a 21G Needle w/Echo Tip.
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-0533-2018. 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.