medical Class II Updated 2022-10-19

Baxter Healthcare Corporation recalls Prismaflex HF20 Set (product code 109841). For use in provi

Recalled Product

Prismaflex HF20 Set (product code 109841). 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 07332414089443, All Lot Codes
View official government recall

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