Baxter recalls Prismaflex ST60, ST100, and ST150 sets due to mistranslated weight restrictions in Eesti language 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 ST60, ST100, and ST150 sets because of a mistranslation in the Eesti language instructions that could lead to incorrect patient weight restrictions. This may cause unsafe use if healthcare providers rely on the mistranslated information.
The Eesti language instructions contain a mistranslation that shows contradictory weight restrictions for patients. This could lead to incorrect weight limits being applied during treatment, potentially causing unsafe fluid management.
Healthcare providers using the Prismaflex ST sets for renal replacement therapies may be affected. Patients receiving treatment with these sets could be at risk if weight restrictions are misapplied.
Check for product codes 107643 (ST60), 107636 (ST100), or 107640 (ST150) on the device. All lot codes are affected, so verify the UDI number on the packaging.
Identify the product code and UDI number to confirm if your set is affected.
The recall is due to a mistranslation in the Eesti language instructions that shows contradictory weight restrictions for patients.
The official notice does not specify a remedy, so check the product details to confirm if it's affected.
The recall indicates a potential for incorrect weight limits, but the official notice does not state a risk of serious injury.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-0084-2023 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-0084-2023 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.
