Arrow PICC Set Recall: Unsealed Packaging May Compromise Sterility

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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 PICC sets with product codes PR-35563-HPHNL and PR-35563-HPHNM because unsealed packaging could compromise sterility. This means the medical devices might not be sterile when used, which is dangerous for patients.

Why it’s dangerous

Unsealed packaging could allow contamination of the PICC set, making it non-sterile. This poses a risk of infection for patients during medical procedures.

Who’s affected

Patients receiving PICC sets from Arrow International are most at risk. Healthcare providers using these specific product codes may also be affected.

How to tell if you have this one

Check for product codes PR-35563-HPHNL or PR-35563-HPHNM. Lot numbers 13F17F0445 (for PR-35563-HPHNL) and 13F17K0495 (for PR-35563-HPHNM) are also affected.

Brand
Arrow
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Codes
Look for product codes PR-35563-HPHNL or PR-35563-HPHNM on the PICC set packaging.

✎ GovInfoNow

Questions people ask

Why is this PICC set being recalled?

The recall is due to unsealed packaging that may compromise sterility, risking infection during medical procedures.

What should I do if I have this PICC set?

Check the product codes and lot numbers to see if your set is affected. If it is, contact Arrow International for guidance.

Are there any specific lot numbers I should check?

Yes, lot numbers 13F17F0445 (for PR-35563-HPHNL) and 13F17K0495 (for PR-35563-HPHNM) are affected.

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-2024-2018 — Arrow Arrow

Hello,

I own a Arrow that is covered by recall Z-2024-2018 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-2024-2018 (April 11, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2024-2018 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 ARROW PICC Set; Product codes: PR-35563-HPHNL and PR-35563-HPHNM

Lower-risk recall