Arrow PleuraSeal Thoracentesis Kit Recall: Packaging Not Fully Sealed

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Recalling firmArrow International Inc2400 Bernville Rd, N/A · Reading, PA 19605-9607

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Arrow is recalling PleuraSeal Thoracentesis Kits because the packaging might not seal properly. This could allow contamination of the medical device, which is used for chest fluid removal. The recall affects specific model numbers sold by Arrow.

Why it’s dangerous

The packaging may not be completely sealed, which could lead to contamination of the medical device. This is a risk during medical procedures where the device is used to remove fluid from the chest.

Who’s affected

Healthcare professionals who use the PleuraSeal Thoracentesis Kit for medical procedures are most at risk. The recall applies to specific model numbers sold by Arrow.

How to tell if you have this one

Check for model numbers AK01000, AK-01000-J, AK-01000-T, or ASK-01000-CHP on the packaging. The product was sold by Arrow International Inc.

Brand
Arrow
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Packaging
Inspect the packaging for model numbers AK01000, AK-01000-J, AK-01000-T, or ASK-01000-CHP.

✎ GovInfoNow

Questions people ask

Is this product dangerous?

The recall states the packaging may not be completely sealed, which could lead to contamination. However, the hazard level is low risk as the remedy does not require immediate stop-use.

What should I do if I have this product?

Check the packaging for model numbers AK01000, AK-01000-J, AK-01000-T, or ASK-01000-CHP. If you have the affected model, you should check the packaging for proper sealing.

How can I get a replacement?

The recall record does not mention a replacement or remedy for this product.

Take action

Contact Arrow

We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1298-2018 — Arrow Arrow

Hello,

I own a Arrow that is covered by recall Z-1298-2018 from Arrow.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-1298-2018 (October 24, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1298-2018 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 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.

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