Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Prismaflex M Set: M150 (product code 109990). For use in Recalled by Baxter Healthcare Corporation Due to Within the current Prismaflex set IFU (instructions for...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Baxter Healthcare Corporation directly.
Affected Products
Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid management and renal replacement therapies.
Quantity: 334,932 devices
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Baxter Healthcare Corporation
Baxter Healthcare Corporation has 401 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report