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FDAMay 31, 2019device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

baxter healthcarebaxter

UPCs

07332414123055

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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