Baxter Healthcare recalls Prismaflex Control Unit (Product Code 114870) due to lack of FDA clearance. Affected units may pose medical risks if used without proper regulatory approval.
Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.
Baxter Healthcare is recalling a specific Prisma:flex Control Unit model that was distributed without FDA approval. Using this unapproved device could lead to medical risks if it's part of a critical healthcare system.
The Prismaflex Control Unit was distributed without FDA regulatory clearance, meaning it hasn't been tested or approved for safety and effectiveness. Using an unapproved medical device could lead to medical risks if it's part of a critical healthcare system.
Healthcare facilities and medical professionals who use the Prismaflex Control Unit with Product Code 114870 are likely affected. Patients relying on this device for critical care may be at risk if the unapproved unit is used.
Check for Product Code 114870 on the device. Affected units were sold with Lot Numbers PA18198, PA18199, PA18238, PA22556, or PA22558.
Look for Product Code 114870 on the Prismaflex Control Unit.
The Prismaflex Control Unit (Product Code 114870) was distributed without FDA regulatory clearance, meaning it hasn't been approved for safety and effectiveness.
The recall record does not specify a remedy, so no action is required beyond checking the product code.
No, the device was distributed without FDA approval, so it may pose medical risks if used in a critical healthcare system.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2066-2020 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-2066-2020 from Baxter Healthcare. 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.
