Reported Nov 16, 2016 · Terminated
GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max…
Baxter Healthcare Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corp. · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
- GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE
- Product code 110634 Product UsageThe Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal failure by hemodialysis
- Lot codes and dates
- C416201601
- Amount recalled
- 22,656 units
Where it was sold
- Nationwide
Why it was recalled
Potential presence of particulate matter on the blood side of the dialyzer
This product could cause temporary or reversible health problems — stop using it.
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