Zoll recalls QUATTRO Intravascular Heat Exchange Catheter Kit (IC-4593AE) 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 QUATTRO Intravascular Heat Exchange Catheter Kit (IC-4593AE) because of potential leaks from the catheter or start-up kit tubing. This could lead to complications if the leaks cause fluid buildup or infection in the bloodstream.
The catheter or start-up kit tubing may leak, potentially causing fluid buildup or infection in the bloodstream. This risk is specific to medical use cases where the kit is connected to a patient's veins.
Healthcare professionals using this catheter kit for central venous infusion are most at risk. Patients receiving treatment with this kit could be affected if leaks occur.
Check for the Zoll QUATTRO Intravascular Heat Exchange Catheter Kit (IC-4593AE) with central venous infusion capabilities. All lots of this product are affected.
Inspect the catheter and start-up kit tubing for signs of leakage.
The recall is due to potential leaks, but the product is still safe to use if no leaks are detected.
Look for the Zoll QUATTRO Intravascular Heat Exchange Catheter Kit (IC-4593AE) with central venous infusion capabilities. All lots are affected.
Check for leaks and contact Zoll if you observe any leakage from the catheter or start-up kit tubing.
We’ve drafted a message you can send Zoll to request your refund or repair — edit it as you like.
Subject: Recall Z-0053-2022 — Zoll Zoll Hello, I own a Zoll that is covered by recall Z-0053-2022 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.
