Health Canada — Medical Devices · Canada · 2019-06-21 · Type II
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Reported risk: Baxter Corporation is issuing a voluntary product recall for REVACLEAR dialyzers due to the potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment. The affected lots were distributed by Baxter canada between 4/22/2019 and 5/21/2019. Blood leaks within the dialyzer may lead to delay in therapy and blood loss equivalent to the extracorporeal circuit. This is expected to result in negligible harm in the majority of patients.
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