ZOLL recalls COOL LINE Intravascular Heat Exchange Catheter Kit (REF 8700-0781-40) 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 COOL LINE Intravascular Heat Exchange Catheter Kit (REF 8700-0781-40) because of potential leaks from the catheter or start-up kit tubing. This could lead to complications if fluids leak during medical procedures.
The catheter or start-up kit tubing may leak, potentially causing fluid to escape during medical procedures. This could lead to complications such as infection or improper treatment if not addressed.
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.
Check for the model number REF 8700-0781-40 (CL-2295AE) on the kit. All lots of this product are affected.
Inspect the catheter and start-up kit tubing for signs of leakage before use.
Yes, all lots of the COOL LINE Intravascular Heat Exchange Catheter Kit (REF 8700-0781-40) 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 or remedy; users should check for leaks before use.
We’ve drafted a message you can send ZOLL to request your refund or repair — edit it as you like.
Subject: Recall Z-0045-2022 — ZOLL ZOLL Hello, I own a ZOLL that is covered by recall Z-0045-2022 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.
