FDAFDA · Food and drugs·Recall number Z-0370-2017
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.
Published November 16, 2016 · Recall initiated: October 12, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential presence of particulate matter on the blood side of the dialyzer
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corp.
- Distributor
- Worldwide Distribution - US Nationwide and the countries of Canada and Mexico.
- Lot
- C416201601
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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