Zoll recalls COOLINE Intravascular Heat Exchange Catheter Kit (REF 8700-0781-03) 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 a specific intravascular heat exchange catheter kit 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 medical procedures, potentially causing complications such as infection or improper treatment. This is a labeling update to inform users about the potential issue.
Healthcare professionals using this catheter kit for medical procedures are most at risk. Patients receiving treatment with this kit may also be affected.
Check for the Zoll COOLINE Intravascular Heat Exchange Catheter Kit with model REF 8700-0781-03 (CL-2295AE). All lots are affected, including those with UDI: (01)00849111050173.
Inspect the catheter and start-up kit tubing for signs of leakage before use.
Yes, all lots of the Zoll COOLINE Intravascular Heat Exchange Catheter Kit (REF 8700-0781-03) are affected.
Check for leaks in the catheter and start-up kit tubing before use. No specific action is required beyond this check.
The recall does not mention a fix; it is a labeling update to inform users about potential leaks.
We’ve drafted a message you can send Zoll to request your refund or repair — edit it as you like.
Subject: Recall Z-0054-2022 — Zoll Zoll Hello, I own a Zoll that is covered by recall Z-0054-2022 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.
