Zoll recalls Cool Line IV Disposable Packs and Start Up Kits due to potential leaks from catheter or tubing. Affected units include all lots of REF 870:000865-01. No remedy specified in recall notice.
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Zoll is recalling all units of their Cool Line IV Disposable Packs and Start Up Kits (6 ft.) because of potential leaks from the catheter or tubing. This could lead to contamination or infection risks if the leaks occur during medical use.
The recall addresses potential leaks from the catheter or the start-up kit tubing. If leaks happen during medical use, they could lead to contamination or infection risks for patients and healthcare workers.
Healthcare professionals using the Cool Line IV system for medical treatments are most at risk. Patients receiving IV therapy with these products may also be affected if leaks occur.
Check for the Zoll Cool Line IV Disposable Pack and Start Up Kit (6 ft.) with model REF 8700-000865-01. All lots of this product are affected.
Identify if your product matches the Zoll Cool Line IV Disposable Pack and Start Up Kit (6 ft.) with model REF 8700-000865-01.
The recall notice does not specify any remedy or fix for the leak issue.
Check for the Zoll Cool Line IV Disposable Pack and Start Up Kit (6 ft.) with model REF 8700-000865-01. All lots of this product are affected.
The recall does not require immediate discontinuation; however, you should check if your product is affected 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-0059-2022 — Zoll Zoll Hello, I own a Zoll that is covered by recall Z-0059-2022 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.
