ZOLL COOL LINE Catheter Kit Recall: Potential Leaks from Tubing

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Recalling firmZOLL Circulation, Inc.2000 Ringwood Ave · San Jose, CA 95131-1728

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

ZOLL is recalling all units of their COOL LINE Intravascular Heat Exchange Catheter Kit (CL-2295) because of potential leaks from the catheter or start-up kit tubing. This could lead to complications during medical procedures if not addressed.

Why it’s dangerous

The catheter or start-up kit tubing may leak, which could cause complications during medical procedures. Leaks might lead to improper treatment or infection risks if not managed correctly.

Who’s affected

Healthcare professionals using the COOL LINE catheter kit for medical procedures are most at risk. Patients receiving treatment with this kit may also be affected.

How to tell if you have this one

Check for the ZOLL COOL LINE Intravascular Heat Exchange Catheter Kit (CL-2295) with the serial number (01)00849111075190. All lots of this product are affected.

Brand
ZOLL
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the product name and serial number to confirm if it matches the recalled kit.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall is due to potential leaks from the catheter or start-up kit tubing, so it is not safe to use without addressing the issue.

How can I tell if I have the recalled product?

Check for the ZOLL COOL LINE Intravascular Heat Exchange Catheter Kit (CL-2295) with the serial number (01)00849111075190. All lots are affected.

What should I do if I have this product?

The recall does not specify a remedy, so contact ZOLL directly for guidance.

Take action

Contact ZOLL

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

✉️ Open in email

Subject: Recall Z-0041-2022 — ZOLL ZOLL

Hello,

I own a ZOLL that is covered by recall Z-0041-2022 from ZOLL.

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-0041-2022 (August 6, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0041-2022 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.

ZOLL Circulation, Inc. recalls ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin,

Lower-risk recall