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.
Other recalls by Medical Action Industries 306
- Generic Name: Kit, Urine, Clean Catch Trade Name: Kit: Urinary Clean Catch 20/cs Model/Catalog Number: 76769 Lot Number: 333606 UDI-DI: 208…
FDA Device · Class III · 2026-10-14 · Medical Action Industries 306 - Blood Culture Collection Venipuncture Kit 20/Cs, REF: 77451
FDA Device · Class II · 2026-09-23 · Medical Action Industries 306 - Kit: Single Shot Epidural 20/Cs, REF: 59553
FDA Device · Class I · 2026-09-16 · Medical Action Industries 306 - Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules
FDA Device · Class I · 2026-09-16 · Medical Action Industries 306 - Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791
FDA Device · Class II · 2026-08-12 · Medical Action Industries 306
All Medical Action Industries 306 recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0464-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.