Baxter recalls Prismaflex HF20 Set (product code 10984:1) due to mistranslation in Eesti instructions causing weight restrictions confusion. Affected units include all lot codes sold globally.
Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions.
Baxter is recalling Prismaflex HF20 Sets because of a mistranslation in the Eesti language instructions that could lead to incorrect patient weight restrictions. This may cause unsafe fluid management if the device is used without proper weight checks.
The mistranslation in the Eesti language instructions contradicts the patient weight restrictions. This could lead to incorrect weight-based fluid management decisions if healthcare providers rely on the mistranslated information.
Patients using the Prismaflex HF20 Set for continuous fluid management or renal replacement therapy are affected. Healthcare providers who use the device with Eesti language instructions are most at risk.
Check for the product code 109841 on the Prismaflex HF20 Set. All lot codes are affected, including those sold globally with UDI 07332414089443.
Check the Eesti language instructions for weight restrictions to ensure they match the current guidelines.
The recall applies to all lot codes sold globally, including US units.
Look for product code 109841 and UDI 07332414089443 on the device. All lot codes are affected.
No immediate stop is required; review the instructions for weight restrictions as the hazard is low risk.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0085-2023 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-0085-2023 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.
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.
