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Baxter Healthcare Corporation Recall: REVACLEAR 400 Dialyzer, Product Code 114746L Revacle

Baxter Healthcare Corporation Recall: REVACLEAR 400 Dialyzer, Product Code 114746L Revacle is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Baxter Healthcare Corporation; Product: REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for tr

Recalling firmBaxter Healthcare Corporation
ProductREVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
Reason for recallThere is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionUS Nationwide Distribution and Internationally to: Canada and Bermuda.
Recall initiated20190531
Recall numberZ-1909-2019
Categorydevice
StateIL
CountryUnited States

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