medical Class II Updated 2019-07-10

Baxter Healthcare Corporation recalls REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 3

Recalled Product

REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.


Hazard / Issue

There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI 07332414124076 Lot Numbers: C419205101 C419205201 C419205301
View official government recall

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