Z-0464-2023Class II

Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile; and Medical Action...

Name: Z-0464-2023 Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile; and Medical Action...
Creator: Medical Action Industries, Inc. 306
Published: 2022-10-12
License: https://open.fda.gov/license/

Medical Action Industries, Inc. 306 / initiated 2022-10-12 / Terminated / root cause: manufacturing process

FDA source

Medical Action Industries, Inc. 306 began a recall of 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... on 2022-10-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0464-2023
Classification: Class II
Status: Terminated
Initiated: 2022-10-12
Posted: 2022-12-08
Terminated: 2025-03-25
Recalling firm: Medical Action Industries, Inc. 306
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.
Product code: OWL Peripheral Catheter Insertion 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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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.
Quantity in commerce: 24 cases (480 kits)
Distribution: Distribution was made to MN. There was no foreign/government/military distribution.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0464-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0464-2023	Class II	Terminated	Voluntary: Firm initiated	2022-12-14	2022-12-08

Product code OWL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)