FDA (Devices) recall action 90841
The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Baxter Healthcare recalls the Prismaflex HF20 Set due to a mistranslation in device instructions that creates contradictory information about patient weight restrictions. The issue affects 29,764 devices distributed nationwide.
Baxter Healthcare is recalling 1,068,560 Prismaflex ST renal replacement therapy sets nationwide. The recall is due to a mistranslation in the Estonian instructions that contains contradictory information about patient weight restrictions.
Baxter Healthcare is recalling Prismaflex M Sets (524,376 devices nationwide) due to a mistranslation in instructions for use that provides contradictory patient body weight restrictions for renal replacement therapy.
Baxter Healthcare recalls Prismaflex HF Set devices due to a mistranslation in Estonian language instructions. The mistranslation contains contradictory information about patient body weight restrictions.
Baxter Healthcare is recalling 334,932 Prismaflex M Set M150 devices due to a mistranslation in instructions that creates contradictory information about patient body weight restrictions.