Zoll recalls QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion due to potential leaks from catheter or start-up kit tubing. All units are affected.
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Zoll is recalling all QUATTRO Intravascular Heat Exchange Catheter Kits with central venous infusion capabilities because of potential leaks from the catheter or start-up kit tubing. This could lead to complications if fluids leak into the bloodstream.
The catheter or start-up kit tubing may leak, potentially causing fluid to enter the bloodstream. This could lead to complications such as infection or improper fluid balance in patients.
Healthcare professionals using the QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities are most at risk. Patients receiving this kit may also be affected if leaks occur.
Check for the Zoll REF: 8700-0783-40 (IC-4593AE) model number on the kit. All lots of this product are affected.
Look for the Zoll REF: 8700-0783-40 (IC-4593AE) model number on the kit.
The recall is due to potential leaks from the catheter or start-up kit tubing, but the product is not unsafe to use under normal conditions.
Check for the Zoll REF: 8700-0783-40 (IC-4593AE) model number on the kit. All lots of this product are affected.
The recall does not specify a remedy, so contact Zoll Circulation, Inc. for further instructions.
We’ve drafted a message you can send Zoll to request your refund or repair — edit it as you like.
Subject: Recall Z-0049-2022 — Zoll Zoll Hello, I own a Zoll that is covered by recall Z-0049-2022 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.