Baxter recalls Prismaflex M Set M150 (product code 109990) due to mistranslation in Eesti instructions causing confusion about patient weight limits for renal treatments.
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 M Set M150 (product code 109990) because instructions for use in Eesti (Estonian) have a mistranslation that could lead to incorrect patient weight restrictions. This affects patients receiving continuous fluid management or renal replacement therapies.
The Eesti language instructions contain a mistranslation that shows contradictory weight restrictions for patients. This could lead to incorrect application of weight limits during treatment, but does not cause immediate harm or injury.
Patients using the Prismaflex M Set M150 for continuous fluid management or renal replacement therapies are affected. Those with the product code 109990 are most at risk due to potential confusion in weight restrictions.
Check for the product code 109990 on the Prismaflex M Set M150. The product is sold for continuous fluid management and renal replacement therapies with UDI 07332414090005.
Look for product code 109990 on the Prismaflex M Set M150 packaging or label.
Baxter recalls the Prismaflex M Set M150 (product code 109990) because Eesti language instructions have a mistranslation that could cause confusion about patient weight restrictions for renal treatments.
Check the product code on your Prismaflex M Set M150. If it matches 109990, contact Baxter for guidance.
The recall is due to potential confusion in weight restrictions, but there is no indication of immediate injury risk. 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-0082-2023 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-0082-2023 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.
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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.
