8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿… — Class II medical device recall Z-1271-2018
Terminated recall by Medical Components, Inc dba MedComp, reported 2018-04-04, distributed in AL, AR, CA. The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. Th
| Recall number | Z-1271-2018 |
|---|---|
| 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 | 2017-11-22 |
| Classified | 2018-03-29 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2018-07-11 |
| Distributed | AL, AR, CA |
| Quantity | 24 eaches |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00884908110449 |
| Lot numbers | MJKK420 |
| Model numbers | MRDP80PLN |
| Expiration dates | 2022-01-09 |
Product
8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyurethane Catheter
Reason for recall
The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire.
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-1271-2018. 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.