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Lower risk Medical device recall · FDA · Published July 26, 2024

Arrow Arterial Kits and Trays: Packaging Open Seals Risk

Arrow recalls 15 specific arterial kits and trays due to open seals on packaging. Consumers should check product references and batch numbers to determine if affected.

🇺🇸 FDA recall #Z-3299-2024Medical deviceArrow ›
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Recalling firmARROW INTERNATIONAL Inc.3015 Carrington Mill Blvd · Morrisville, NC 27560-5437
✎ GovInfoNow plain-language explainer

What happened, in plain English

Arrow is recalling 15 different arterial kits and trays because reports show open seals on their packaging. This could lead to contamination or improper use of medical devices. Read more at govinfonow.com/recall/54413-arrow-arterial-kits-and-trays-packaging-open-seals-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/54413-arrow-arterial-kits-and-trays-packaging-open-seals-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-3299-2024

Cite this page

“Arrow Arterial Kits and Trays: Packaging Open Seals Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54413-arrow-arterial-kits-and-trays-packaging-open-seals-risk. Based on FDA recall #Z-3299-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3299-2024%22&limit=1).

Why it’s dangerous

Open seals on packaging could allow contaminants to enter the kit, potentially causing infections or improper use during medical procedures. However, the kits themselves are not defective and function normally when sealed properly.

Who’s affected

Medical professionals who use Arrow arterial kits and trays for procedures like catheterization. Patients receiving these procedures are at minimal risk if the kits are used properly.

How to tell if you have this one

Check the product reference (REF) codes and batch numbers listed in the recall notice. For example, REF ASK-04001-BW1 has batch numbers 33F23M0157, 33F23L0297, etc.

  • Brand
    Arrow
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the product reference (REF) codes and batch numbers listed in the recall notice to determine if your item is affected.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 11 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: named in the noticeWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of CA, FL, GA, IL, MA, ME, MI, NC, NY, PA, and WV. There was government distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Florida, Georgia, Illinois, Maine, Massachusetts, Michigan, New York, North Carolina, Pennsylvania, West Virginia.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Jul 26, 202412. FDA classified it Class II: Sep 26, 202423. Published in FDA’s Enforcement Report: Oct 2, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

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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-3299-2024 (July 26, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3299-2024 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