Baxter Healthcare Corp. recalls GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dia…
- Recall date
- October 12, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0370-2017
- FDA classification
- Class II
- Brand / firm
- Baxter Healthcare Corp.
- Sold / distributed
- Worldwide Distribution - US Nationwide and the countries of Canada and Mexico.
Why it was recalled
Potential presence of particulate matter on the blood side of the 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
GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal failure by hemodialysis.
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