Zoll recalls ICY Intravascular Heat Exchange Catheter Kit (REF 8700-0695-40) due to potential leaks from catheter or start-up kit tubing. All lots affected.
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Zoll is recalling its ICY Intravascular Heat Exchange Catheter Kit (REF 8700-0695-40) because of potential leaks from the catheter or start-up kit tubing. This could lead to complications during medical procedures if not addressed.
The catheter or start-up kit tubing may leak during use, which could cause complications such as infection or improper treatment delivery. This is a labeling update issue, not a defect in the product itself.
Healthcare professionals using this catheter kit for intravascular procedures are most at risk. Patients receiving treatment with this kit may also be affected.
Check for the product name 'ICY Intravascular Heat Exchange Catheter Kit' with reference number REF 8700-0695-40 (IC-3893AE). All lots are affected.
Verify the product name and reference number to confirm if your kit is affected.
Yes, all lots of this specific kit are affected.
The recall does not specify a remedy, so check with Zoll for further instructions.
The recall notes potential leaks but does not indicate a risk of serious injury, so this is considered low risk.
We’ve drafted a message you can send Zoll to request your refund or repair — edit it as you like.
Subject: Recall Z-0056-2022 — Zoll Zoll Hello, I own a Zoll that is covered by recall Z-0056-2022 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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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.
