Baxter recalls Prismaflex M Set M60 and M100 models due to mistranslation in weight restrictions instructions, potentially causing incorrect patient weight limits.
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 models M60 and M100 because of a mistranslation in the instructions for use that could lead to incorrect patient weight restrictions. This might cause unsafe fluid management if the device is used with patients outside the intended weight range.
The instructions for use contain a mistranslation of the Extonian (Eesti) text that shows contradictory weight restriction information. This could lead to using the device with patients outside the intended weight range, potentially causing unsafe fluid management.
Patients using these specific Prismaflex M Set models for continuous fluid management or renal replacement therapies. Healthcare providers who administer these devices to patients are most at risk of using incorrect weight limits.
Check for product codes 106696 (M60) or 106697 (M100) on the device. These sets are used for continuous fluid management and renal replacement therapies.
Look for product codes 106696 (M60) or 106697 (M100) on the device label.
Baxter recalls these Prismaflex M Set models due to a mistranslation in the instructions for use that shows contradictory weight restriction information.
Check the product code on the device label. If it matches 106696 or 106697, contact Baxter for guidance.
The recall is due to a potential mistranslation in weight restrictions, but no specific injury risk is mentioned in the official notice.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-0081-2023 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-0081-2023 from Baxter. 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.
