Medical Action Industries Inc — Class II medical device recall Z-0464-2023
Terminated recall by Medical Action Industries, Inc. 306, reported 2022-12-14, distributed in MN. The Port Access Kits were incorrectly labeled as IV Start Kits on the kit label. The case label was correctly
| Recall number | Z-0464-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medical Action Industries, Inc. 306, Arden, NC, United States |
| Recall initiated | 2022-10-12 |
| Classified | 2022-12-08 |
| Reported by FDA | 2022-12-14 |
| Terminated | 2025-03-25 |
| Distributed | MN |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 20809160195991 |
| Lot numbers | 294281, 294589 |
| Model numbers | 76511B, 78019 |
| Expiration dates | 2023-09-28, 2024-12-20 |
Product
Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile; and Medical Action Industries Inc. IV Start Kit, REF #78019 (on kit label), sterile. Kit components are the Port Access Kit.
Reason for recall
The Port Access Kits were incorrectly labeled as IV Start Kits on the kit label. The case label was correctly labeled as Port Access Kits.
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-0464-2023. 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.