Zoll recalls QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion. Potential leaks from catheter or start-up kit tubing may cause complications. Check product details to determine if affected.
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Zoll is recalling a specific model of intravascular heat exchange catheter kit due to potential leaks from the catheter or start-up kit tubing. This could lead to complications if the kit leaks during medical use.
The catheter or start-up kit tubing may leak, which could cause complications during medical procedures. Leaks might lead to improper fluid delivery or infection risks if not properly managed.
Healthcare professionals using the Zoll QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities are most likely affected. Patients receiving this kit are at risk if leaks occur during medical procedures.
Check for the Zoll REF: 8700-0783-14 (IC-4593CO) model number on the kit. This product was sold with central venous infusion capabilities and is labeled as HEPARIN COATED, Sterile EO, Rx Only.
Identify the model number on the kit to confirm if it matches Zoll REF: 8700-0783-14 (IC-4593CO).
The recall affects healthcare professionals using the kit, but patients receiving the kit may be at risk if leaks occur during medical procedures.
Check for the model number Zoll REF: 8700-0783-14 (IC-4593CO) on the kit, which includes central venous infusion capabilities and is labeled as HEPARIN COATED, Sterile EO, Rx Only.
The recall record does not specify a remedy, so contact Zoll directly for guidance.
We’ve drafted a message you can send Zoll to request your refund or repair — edit it as you like.
Subject: Recall Z-0051-2022 — Zoll Zoll Hello, I own a Zoll that is covered by recall Z-0051-2022 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.
