Medical Action Industries Inc. Port Access Kit, REF #76511B… recallZ-0464-2023 · Medical Action Industries, Inc. 306 · initiated Oct 12, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medical Action Industries, Inc. 306 or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Employee error
What the company is doing
The recalling firm issued a letter dated 10/12/2022 to their only consignee via email on 10/12/2022. The letter informed the consignee the kits were incorrectly labeled as reference number 78019, the IV Start Kit, but the case label correctly lists the item as the Port Access Kit. The consignee was requested to review their inventory and segregate and quarantine all affected kits labeled as IV Start Kit, lot #294589. If any of the affected kits were further distributed, the consignee was requested to ensure all end users were appropriately notified of the recall. The consignee was to contact the firm for return of the affected kits. A Field Action Response Form was enclosed for completion and return to the firm via email to indicate they have read and understood the recall instructions, checked their inventory, indicated how much was in inventory, and have notified appropriate staff and customers of the recall.
Recall details
- Recall number
- Z-0464-2023
- Status
- Terminated
- Initiated by the company
- Oct 12, 2022
- Posted by the FDA
- Dec 8, 2022
- Recalling firm
- Medical Action Industries, Inc. 306
- Quantity
- 24 cases (480 kits)
- Product code
- OWL
- Distribution
- Distribution was made to MN. There was no foreign/government/military distribution.
Product description
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.
Code information (models, lots, serial numbers)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MEDICAL ACTION INDUSTRIES 78019Medical Action Industries Inc. · I.V. start kit1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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