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Lower risk Medical device recall · FDA · Published October 12, 2022

Medical Action Industries Port Access Kit Recalled: Incorrect Labeling

Medical Action Industries recalls Port Access Kits with incorrect IV Start Kit labeling. This labeling error may cause confusion in medical use. Affected kits have specific lot numbers and expiration dates.

🇺🇸 FDA recall #Z-0464-2023Medical deviceMedical Action Industries ›
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Recalling firmMedical Action Industries, Inc. 30625 Heywood Rd · Arden, NC 28704-9302
✎ GovInfoNow plain-language explainer

Medical Action Industries is recalling Port Access Kits that were incorrectly labeled as IV Start Kits. This labeling error could lead to confusion during medical procedures, potentially causing incorrect use of the kit. Read more at govinfonow.com/recall/59921-medical-action-industries-port-access-kit-recalled-incorrect-labeling.

Source Summary by GovInfoNow · govinfonow.com/recall/59921-medical-action-industries-port-access-kit-recalled-incorrect-labeling · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0464-2023

Cite this page

“Medical Action Industries Port Access Kit Recalled: Incorrect Labeling.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59921-medical-action-industries-port-access-kit-recalled-incorrect-labeling. Based on FDA recall #Z-0464-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0464-2023%22&limit=1).

The FDA announced on Oct. 12, 2022, that Medical Action Industries Inc. is recalling Port Access Kits because they were incorrectly labeled as IV Start Kits on the kit label. The agency issued recall number Z-0464-2023 for the voluntary Class II recall.

How to tell if you have it

  • Brand: Medical Action Industries
  • Product: Port Access Kit, REF #76511B (on case label), sterile
  • Product: IV Start Kit, REF #78019 (on kit label), sterile
  • Lot code: 294281, exp. 9/28/2023, UDI #1080916018095
  • Lot code: 294589, exp. 12/20/2024, UDI #20809160195991
  • Quantity: 24 cases (480 kits)
  • Distribution: MN

The hazard

According to the FDA, 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.

Context

GovInfoNow's records show Medical Action Industries, Inc. 306 has 14 other recalls on record since 2019-12-02. Other recent recalls of similar products include Medical Action Industries Blood Culture Kits Risk Localized Infection Due to Packaging Seal (2026-07-23), Medical Action Industries Epidural Pain Kit Recall: Potentially Compromised Sterility Risk (2026-07-23), and Medical Action Industries Dialysis Change Tray Clear Sequence: Silicone Seal Risk (2026-05-21). Other recent recalls of similar products include Medline Medical Procedure Kits Recall: Catheter Issues (2026-05-04) and Medline TRACH TUBE KIT Recall: Labeling Discrepancy Hazard (2026-07-10).

How to tell if you have this one

Check the case label for lot number 294281 (exp. 9/28/2023) or lot number 294589 (exp. 12/20/2024). The kits are sterile and labeled as either Port Access Kits or IV Start Kits.

  • Brand
    Medical Action Industries
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Label

    Look for the case label with lot number 294281 (exp. 9/28/2023) or lot number 294589 (exp. 12/20/2024).

Where it went and when

Where it was distributed

Distributed in Minnesota.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “Distribution was made to MN. There was no foreign/government/military distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Minnesota.

Recall timeline

FDA terminated this recall 2.5 years after the firm started it.

1. Firm started the recall: Oct 12, 202212. FDA classified it Class II: Dec 8, 202223. Published in FDA’s Enforcement Report: Dec 14, 202234. FDA terminated the recall: Mar 25, 2025420222025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Are there any risks to patients?

The labeling error could lead to incorrect use, but the recall is for labeling issues, not a safety hazard.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0464-2023 (October 12, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0464-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA