Medical device recalls Moderate risk

Baxter Healthcare Corporation recalls Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L

Recall date
November 15, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1409-2020
FDA classification
Class II
Brand / firm
Baxter Healthcare Corporation
Sold / distributed
Nationwide

Why it was recalled

There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer.

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 Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L

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