FDAFDA · Food and drugs·Recall number Z-0490-2015
Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.
Published December 10, 2014 · Recall initiated: November 5, 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
Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Dialyzer due to potential tears in the individual packaging that may compromise the sterile barrier.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Gambro Renal Products Inc
- Distributor
- Worldwide Distribution: US (nationwide) including PR, and countries of: CA, BB, BM, BS, DO and LC.
- Lot
- Lot No C412207001 to C412209101, C413200101 to C413206001, C414200101 to C414206001
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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