Vyaire Medical recalls enFlow Disposable Cartridges for intravenous warming therapy due to aluminum elution during fluid warming. 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 used for intravenous warming therapy because testing found aluminum elution during fluid warming. This could pose a risk to patients receiving the therapy.
Aluminum elution means aluminum is leaking from the cartridge into the fluid being warmed. This could cause aluminum toxicity in patients receiving intravenous therapy, potentially leading to serious health issues.
Healthcare professionals using the enFlow Disposable Cartridges for intravenous warming therapy with fluids and blood solutions are likely affected. Patients receiving this therapy are at risk if they use the recalled cartridges.
The enFlow Disposable Cartridge has part number 980200EU. All units distributed through March 7, 2019 are affected.
Immediately stop using the enFlow Disposable Cartridge for intravenous warming therapy if you have it.
The enFlow Disposable Cartridge is used for intravenous warming therapy with fluid and blood solutions.
All units distributed through March 7, 2019 are affected.
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-1385-2019 — Vyaire Medical Vyaire Medical Hello, I own a Vyaire Medical that is covered by recall Z-1385-2019 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
