Zoll recalls Quattro (Heparin) IV Disposable Packs and Start-Up Kits (6 ft.) due to potential leaks from catheter or tubing. All lots affected in EU.
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Zoll is recalling its Quattro (Heparin) IV Disposable Packs and Start-Up Kits (6 ft.) in the EU because of potential leaks from the catheter or tubing. This could lead to improper medication delivery or contamination if leaks occur.
The labeling update indicates that the catheter or tubing in the Start-Up Kit may leak. Leaks could cause medication to be delivered improperly or contaminate the patient's bloodstream.
Healthcare professionals using the Quattro IV system in the EU are affected. Patients receiving IV treatments with this kit are at risk if leaks occur.
Check for the Zoll Quattro (Heparin) IV Disposable Pack and Start-Up Kit (6 ft.) with the EU New Luer connector. All lots are affected in the EU.
Inspect the catheter and tubing for signs of leakage before use.
Yes, all lots of the Quattro (Heparin) IV Disposable Pack and Start-Up Kit (6 ft.) with EU New Luer connector are affected.
The recall includes a labeling update about potential leaks from the catheter or tubing, but specific leak indicators are not described in the notice.
No, the recall does not require immediate discontinuation; users should check for leaks before use.
We’ve drafted a message you can send Zoll to request your refund or repair — edit it as you like.
Subject: Recall Z-0065-2022 — Zoll Zoll Hello, I own a Zoll that is covered by recall Z-0065-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
