Zoll recalls SOLEX 7 Heparin IV Disposable Packs and Start-Up Kits (6 ft.) due to potential leaks from catheter or tubing. All lots affected in EU markets.
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Zoll is recalling its SOLEX 7 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 during use.
The labeling update indicates that the catheter or tubing in the kit may leak during use. Leaks could cause improper medication delivery or contamination of the IV solution, potentially leading to patient harm.
Healthcare professionals using the Zoll SOLEX 7 Heparin IV Kit in EU markets are most at risk. Patients receiving IV treatments with this kit could be affected if leaks occur.
Check for the Zoll SOLEX 7 Heparin IV Disposable Pack and Start-Up Kit (6 ft.) with the EU New Luer connector. All lots in the EU market are affected.
Identify the product by checking for the EU New Luer connector and the specific lot number on the packaging.
No, this recall specifically affects Zoll SOLEX 7 Heparin IV Disposable Packs and Start-Up Kits (6 ft.) with the EU New Luer connector in the EU market.
The recall record does not specify a remedy, so no action is required beyond checking if you have the affected product.
The recall mentions potential leaks but does not state that leaks can cause serious injury or death. The hazard level is low risk.
We’ve drafted a message you can send Zoll to request your refund or repair — edit it as you like.
Subject: Recall Z-0066-2022 — Zoll Zoll Hello, I own a Zoll that is covered by recall Z-0066-2022 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.