Zoll ICY Intravascular Heat Exchange Catheter Kit Recall: Potential Leaks

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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 its ICY Intravascular Heat Exchange Catheter Kit (REF: 8700-0782-01) because of potential leaks from the catheter or start-up kit tubing. This could lead to complications if the leaks cause fluid or blood to escape during medical procedures.

Why it’s dangerous

The catheter or start-up kit tubing may leak during use, potentially causing fluid or blood to escape from the bloodstream. This could lead to complications such as infection or improper medication delivery if not detected.

Who’s affected

Healthcare professionals using this catheter kit for central venous infusion procedures are affected. Patients receiving treatment with this kit may be at risk if leaks occur.

How to tell if you have this one

Check for the Zoll REF: 8700-0782-01 (IC-3893) label on the kit. All lots of this product are affected, including those with UDI: (01)00849111075237.

Brand
Zoll
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the Zoll REF: 8700-0782-01 (IC-3893) label on the kit. All lots are affected.

✎ 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, which could cause complications. However, the product is not unsafe if leaks are detected and addressed.

How can I tell if I have the recalled product?

Check for the Zoll REF: 8700-0782-01 (IC-3893) label on the kit. All lots with UDI: (01)00849111075237 are affected.

What should I do if I have the recalled product?

The recall does not specify a remedy, so contact Zoll directly for guidance on next steps.

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-0039-2022 — Zoll Zoll

Hello,

I own a Zoll that is covered by recall Z-0039-2022 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-0039-2022 (August 6, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0039-2022 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: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion

Lower-risk recall