Zoll recalls QUATTRO Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin 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 all QUATTRO Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin products because of potential leaks from the catheter or start-up kit tubing. This could lead to complications during medical procedures if not addressed.
The catheter or start-up kit tubing may leak, which could cause complications during medical procedures. Leaks might lead to contamination or improper treatment if not detected and managed promptly.
Healthcare professionals using the QUATTRO Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin are affected. Patients receiving this equipment during medical procedures may be at risk if leaks occur.
Check for the product name 'QUATTRO Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin' with the serial number (01)00849111075282. All lots of this product are affected.
Verify the product name and serial number (01)00849111075282 to confirm if it is affected.
The recall is due to potential leaks from the catheter or start-up kit tubing, but the product is still safe to use if leaks are detected and addressed promptly.
Check for the product name 'QUATTRO Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin' with the serial number (01)00849111075282. All lots are affected.
The recall does not specify a remedy, so contact Zoll Circulation, Inc. for guidance on next steps.
We’ve drafted a message you can send Zoll to request your refund or repair — edit it as you like.
Subject: Recall Z-0048-2022 — Zoll Zoll Hello, I own a Zoll that is covered by recall Z-0048-2022 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.
