FDAFDA · Food and drugs·Recall number Z-1644-2014
Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
Published May 28, 2014 · Recall initiated: April 16, 2014
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
The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Gambro Renal Products, Incorporated
- Distributor
- Worldwide Distribution -- USA, including the territory of Puerto Rico, and the countries of Bermuda and Australia.
- Lot
- Lot Numbers: C413204601, C413204801, C413204901, C413205101, C413205201, C413205301, C413205401, C413205501, C413205601, C413205701, C413205801, C413205901, C413206001, C414200101, C414200201, C414200301, C414200401, C414200701, C414200801, C414200901, C414201301, C414201401, C414201501, and C414201601.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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