medical Class II Updated 2022-10-19

Baxter Healthcare Corporation recalls Prismaflex ST Set: ST60 (product code 107643), ST100 (produ

Recalled Product

Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product code 107640). For use in providing continuous fluid management and renal replacement therapies.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: 07332414075682 (product code 107643), 07332414075613 (product code 107636), 07332414075651 (product code 107640); All Lot Codes
View official government recall

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