Zoll recalls ICY Intravascular Heat Exchange Catheter Kit (REF 8700-0782-03) 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 8700-0782-03) 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, potentially causing complications during medical procedures. Leaks could lead to fluid loss or infection if not properly managed.
Healthcare professionals using the ICY Intravascular Heat Exchange Catheter Kit for medical procedures are likely affected. Patients receiving this equipment may be at risk if leaks occur.
Check for the product name 'ICY Intravascular Heat Exchange Catheter Kit' with reference number REF 8700-0782-03. All lots of this product are affected.
Verify the product reference number REF 8700-0782-03 and all lots are affected.
Yes, all lots of the ICY Intravascular Heat Exchange Catheter Kit (REF 8700-0782-03) are affected.
The recall does not specify a remedy, so contact Zoll Circulation, Inc. for further instructions.
The recall mentions potential leaks but does not specify serious injury risks, so the danger level is 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-0055-2022 — Zoll Zoll Hello, I own a Zoll that is covered by recall Z-0055-2022 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.
