Polyflux Revaclear Max Dialyzer recall: Sterility Concern
Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended…
Why was Polyflux Revaclear Max Dialyzer recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot No C412207001 to C412209101, C413200101 to C413206001, C414200101 to C414206001
- Product
- Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended…
- Recalling firm
- Gambro Renal Products Inc
- Quantity
- 20 million dialyzers
- Distribution
- Worldwide Distribution: US (nationwide) including PR, and countries of: CA, BB, BM, BS, DO and LC.
- Recall date
- December 10, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)