Reported May 28, 2014 · Terminated
Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of…
Gambro Renal Products, Incorporated
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: Gambro Renal Products, Incorporated · 14143 Denver West Pkwy · Lakewood, CO · 80401-3266
Is this the product you have?
- Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
- Lot codes and dates
- Lot Numbers
64 of 64 codes
C413124101C413124301C413124501C413124601C413124701C413124801C413124901C413125001C413125101C413125201C413125301C413125401C413125501C413125601C413125701C413125801C413125901C413126001C413126101C413126201C413126301C413126401C413126501C413126601C413126701C413126801C413126901C413127001C413127101C413127201C413127301C413127401C413127501C413127601C413127701C413127801C413127901C413128001C413128101C413128201C413128401C413128501C413128601C413128701C413128801C413128901C413129001C413129101C413129201C413129301C413129401C413129501C413129601C414100101C414100601C414101001C414101201C414101401C414102101C414102301
- Lot Numbers
- Amount recalled
- 2,461,824 units total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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