Optiflux B200 Flux Dialyzers recall
Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute or chronic hemanalysis treatment.
Why was Optiflux B200 Flux Dialyzers recalled?
Dialysate Port Leak During Priming of the Dialyzers
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 Numbers: 13LU02011 13LU02013 13NU02016 13NU02017
- Product
- Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute or chronic hemanalysis treatment.
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 100,008 units
- Distribution
- Worldwide distribution: USA (nationwide) and the country of: Mexico.
- Recall date
- March 5, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)