FDA Device recall Z-0464-2023
Medical Action Industries Inc
- FDA Device
- Class II
- terminated
- Published 2022-12-14
On 2022-12-14 the FDA classified a Class II recall of Medical Action Industries Inc by Medical Action Industries 306, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0464-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-10-12 |
| Published | 2022-12-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medical Action Industries 306 |
| Distribution | MN |
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
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.
Identifiers
| code_info | Port Access Kit case label - Lot 294281, exp. 9/28/2023, UDI #1080916018095. IV Start Kit label - Lot 294589, exp. 12/20/2024, UDI #20809160195991. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0464-2023%22
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