FDA MedWatch: Recall Baxter REVACLEAR 300 Dialyzer and Baxter REVACLEAR 400 Dialyzer

July 8, 2019

The FDA has announced a Class II recall of 59 lots of Baxter Revaclear 300 Dialyzer, Product Code 114745L, and 3 lots of Baxter Revaclear 400 Dialyzer, Product Code 114746L, totaling 1.3 million units.  These HD dialyzers may leak blood during dialysis because there is potential for fibers in the dialyzer to rupture.  

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