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.
Reported: November 16, 2016 Initiated: October 12, 2016 #Z-0370-2017
Product Description
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.
Reason for Recall
Potential presence of particulate matter on the blood side of the dialyzer
Details
- Recalling Firm
- Baxter Healthcare Corp.
- Units Affected
- 22,656 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Canada and Mexico.
- Location
- Deerfield, IL
Frequently Asked Questions
What product 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.. Recalled by Baxter Healthcare Corp.. Units affected: 22,656 units.
Why was this product recalled? ▼
Potential presence of particulate matter on the blood side of the dialyzer
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 16, 2016. Severity: Moderate. Recall number: Z-0370-2017.
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