Arrow Percutaneous Sheath Kit Recall: Latex Risk in Catheter Kits

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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 Percutaneous Sheath Introducer Kits for 7-7.5 Fr. catheters because they contain natural rubber latex, even though the label says 'Latex Free'. This could cause allergic reactions in people sensitive to latex.

Why it’s dangerous

The kit contains natural rubber latex, which can cause allergic reactions in sensitive individuals. The label claims it's latex-free, but the product actually contains latex.

Who’s affected

Healthcare professionals and patients using the kit for catheter procedures. Those with latex allergies are at higher risk.

How to tell if you have this one

Check for the kit model REF ES-09807. The product is for 7-7.5 Fr. catheters with an 8 Fr. 10 cm sheath length. Lot/Batch Number 13F18A0037 was produced until April 2019.

Brand
Arrow
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the kit model REF ES-09807 and lot/batch number 13F18A0037 on the packaging.

✎ GovInfoNow

Questions people ask

Is this kit safe for people with latex allergies?

No, the kit contains natural rubber latex despite labeling as 'Latex Free', which can cause allergic reactions in sensitive individuals.

What should I do if I have this kit?

The recall record does not specify a remedy, so no action is required beyond checking if you have the affected kit.

When was this kit produced?

The kit was produced with lot/batch number 13F18A0037 and expired by April 2019.

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-2576-2018 — Arrow Arrow

Hello,

I own a Arrow that is covered by recall Z-2576-2018 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-2576-2018 (May 23, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2576-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 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.

Arrow International Inc recalls Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia.

Lower-risk recall