Zoll recalls ICY Intravascular Heat Exchange Catheter Kit with central venous infusion. Potential leaks from catheter or start-up kit tubing. Affected units have specific model and lot numbers.
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 with central venous infusion capabilities due to potential leaks from the catheter or start-up kit tubing. This could lead to complications if the kit leaks during medical procedures.
The catheter or start-up kit tubing may leak, which could cause complications during medical procedures. Leaks might lead to infection or other issues if the kit is used improperly.
Healthcare professionals using the ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities are most at risk. Patients receiving this kit during medical procedures may also be affected.
Check for the model number ZOLL REF: 8700-0782-14 (IC-3893CO) on the kit. All lots of this product are affected, so any unit with this model number should be considered recalled.
Look for the model number ZOLL REF: 8700-0782-14 (IC-3893CO) on the kit to confirm if it is affected.
Yes, all units with model number ZOLL REF: 8700-0782-14 (IC-3893CO) are affected by this recall.
Check the model number on the kit to confirm if it is affected. If it is, contact Zoll for further instructions.
The recall does not specify a remedy, so you should check the model number and contact Zoll if you have the affected model.
We’ve drafted a message you can send Zoll to request your refund or repair — edit it as you like.
Subject: Recall Z-0050-2022 — Zoll Zoll Hello, I own a Zoll that is covered by recall Z-0050-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
