Vyaire Medical recalls enFlow Disposable Cartridges with IV Extension Sets due to aluminum elution during fluid warming therapy. Affected units distributed through March 7, 2019.
Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.
Vyaire Medical is recalling enFlow Disposable Cartridges with IV Extension Sets used for intravenous warming therapy because testing found aluminum elution during fluid warming. This could pose a risk to patients receiving IV treatments.
Aluminum elution occurs when aluminum from the cartridge leaks into the fluid being warmed. This can happen during the warming process and may lead to aluminum toxicity in patients receiving intravenous fluids.
Healthcare providers using the enFlow Disposable Cartridges with IV Extension Sets for intravenous warming therapy are affected. Patients receiving IV treatments with these cartridges may be at risk.
Check for the enFlow Disposable Cartridge with IV Extension Set, part number 980202EU. All units distributed through March 7, 2019 are affected.
Identify the part number 980202EU on the enFlow Disposable Cartridge with IV Extension Set.
Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.
All units distributed through March 7, 2019.
The recall record does not specify a remedy.
We’ve drafted a message you can send Vyaire Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1386-2019 — Vyaire Medical Vyaire Medical Hello, I own a Vyaire Medical that is covered by recall Z-1386-2019 from Vyaire Medical. 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.
