medical Class II Updated 2022-10-19

Baxter Healthcare Corporation recalls Prismaflex M Set: M60 (product code 106696), M100 (product

Recalled Product

Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). 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: 07332414064549 (product code 106696), 07332414064556 (product code 106697); All lot codes
View official government recall

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