Zoll recalls Quattro 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 Quattro 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 labeling update indicates that the catheter or start-up kit tubing might leak. Leaks could cause contamination or infection if the equipment is used in medical settings.
Healthcare professionals using the Quattro IV system for medical purposes are most at risk. Patients receiving care with this equipment may also be affected if leaks occur.
Check for the Zoll Quattro IV Disposable Pack and Start Up Kit (6 ft.) model with the specific reference number 8700-000867-01. All lots of this product are affected.
Identify if your Quattro IV Disposable Pack and Start Up Kit (6 ft.) has the reference number 870:000867-01.
Yes, all lots of the Zoll Quattro IV Disposable Pack and Start Up Kit (6 ft.) with reference number 8700-000867-01 are affected.
The recall does not specify a remedy, so contact Zoll directly for guidance on next steps.
The recall mentions potential leaks but does not state that leaks can cause serious injury or death.
We’ve drafted a message you can send Zoll to request your refund or repair — edit it as you like.
Subject: Recall Z-0061-2022 — Zoll Zoll Hello, I own a Zoll that is covered by recall Z-0061-2022 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.
