Baxter Healthcare Corporation recalls REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of c…

Recall date

May 31, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1908-2019

FDA classification

Class II

Brand / firm

Baxter Healthcare Corporation

Sold / distributed

US Nationwide Distribution and Internationally to: Canada and Bermuda.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.