Zoll recalls ICY IV Disposable Packs and Start Up Kits due to potential leaks from catheter or tubing. Affected units include all lots of the specific model.
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Zoll is recalling its ICY IV Disposable Packs and Start Up Kits (6 ft.) because of potential leaks from the catheter or tubing. This could lead to contamination or improper fluid delivery during medical use.
The labeling update indicates that the catheter or tubing in the disposable pack could leak during use. This might cause contamination or improper fluid delivery, which could affect patient safety.
Healthcare professionals using the ICY IV Disposable Packs and Start Up Kits for medical procedures are most at risk. Patients receiving treatment with these products may also be affected.
Check for the Zoll ICY IV Disposable Pack and Start Up Kit (6 ft.) with the model reference REF 870: 8700-000866-01. All lots of this specific model are affected.
Look for the model reference REF 8700-000866-01 on the product label.
The recall is due to potential leaks from the catheter or tubing, but the product is still safe to use if the leaks are not present.
Check for the model reference REF 8700-000866-01 on the product label. All lots of this specific model are affected.
The recall does not specify a remedy, so you should check with Zoll for further instructions.
We’ve drafted a message you can send Zoll to request your refund or repair — edit it as you like.
Subject: Recall Z-0060-2022 — Zoll Zoll Hello, I own a Zoll that is covered by recall Z-0060-2022 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.
