Baxter recalls Prismaflex HF Set models HF1000 and HF1400 due to mistranslation in Eesti language instructions causing confusion about patient weight limits. Affected units may need reevaluation of safety.
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 two models of Prismaflex HF Sets used for continuous fluid management because of a mistranslation in the Eesti language instructions that could lead to incorrect patient weight restrictions. This might cause unsafe use if healthcare providers follow the wrong weight limits.
The Eesti language instructions for the Prismaflex HF Set contain a mistranslation that shows conflicting information about patient weight limits. This could lead to incorrect weight restrictions being applied during treatment, potentially causing unsafe conditions.
Healthcare providers using the Prismaflex HF Set for continuous fluid management or renal replacement therapies are most at risk. Patients receiving treatment with these sets could be affected if weight restrictions are misunderstood.
Check for product codes 107140 (HF1000) or 107142 (HF1400) on the device. All lot codes are affected, so any unit with these product codes should be considered recalled.
Check the Eesti language instructions for weight restrictions to ensure they match the current guidelines.
The recall is for healthcare providers using the device. Patients are not directly affected unless their treatment is based on incorrect weight restrictions.
Check the product code on the device. If it's 107140 or 107142, it's affected and you should review the instructions for weight restrictions.
The official recall does not provide a fix; healthcare providers must review the instructions to ensure correct weight restrictions are used.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0083-2023 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-0083-2023 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.
