Zoll recalls Cool Line Heparin IV Disposable Packs and Start-Up Kits (EU, New Luer) due to potential leaks from catheter or tubing. Affected units may need replacement.
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Zoll is recalling Cool Line Heparin IV Disposable Packs and Start-Up Kits (EU, New Luer) 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 could leak. Leaks might cause medication to spill, potentially leading to contamination or improper dosing if not properly managed.
Healthcare professionals using the Cool Line Heparin IV system in Europe are likely affected. Patients receiving IV treatments with this kit may be at risk if leaks occur.
Check for the Cool Line (Heparin) IV Disposable Pack and Start-Up Kit (6 ft.) with the EU New Luer connector. This product was sold in Europe with the specific model number REF 8700-000869-40.
Verify if your Cool Line Heparin IV Kit has the model number REF 8700-000869-40 with the EU New Luer connector.
The recall applies to Cool Line Heparin IV Disposable Packs and Start-Up Kits (6 ft.) with the EU New Luer connector and model number REF 8700-000869-40. Check your kit's details to confirm.
The recall does not specify a remedy, so contact Zoll directly for guidance on whether replacement is needed.
The recall mentions potential leaks, but the official notice does not state that leaks can cause serious injury or death. This is a low-risk issue.
We’ve drafted a message you can send Zoll to request your refund or repair — edit it as you like.
Subject: Recall Z-0063-2022 — Zoll Zoll Hello, I own a Zoll that is covered by recall Z-0063-2022 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.
