Zoll recalls Premium Access Kit QUATTRO (IC-4593) due to potential leaks from the catheter or start-up kit tubing. Affected units have specific model and lot numbers.
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Zoll is recalling its Premium Access Kit QUATTRO (IC-4593) because of potential leaks from the catheter or start-up kit tubing. This could lead to complications during medical procedures if not addressed.
The labeling update indicates a potential for leaks from the catheter or the start-up kit tubing. Leaks could cause complications during medical procedures if not properly managed.
Healthcare professionals using the kit for intravascular procedures are most at risk. Patients receiving treatment with this kit may also be affected.
Check for the model number IC-4593 on the product label. The kit includes a central venous infusion system with 3 lumens and is designed for femoral vein insertion only.
Look for the model number IC-4593 on the product label to confirm if it is affected.
The recall is due to potential leaks from the catheter or start-up kit tubing, but the kit remains safe for use if proper procedures are followed.
Check for the model number IC-4593 on the product label. The kit has specific features like central venous infusion capabilities and is designed for femoral vein insertion only.
The recall does not specify a remedy, so contact Zoll directly 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-0040-2022 — Zoll Zoll Hello, I own a Zoll that is covered by recall Z-0040-2022 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.