Optiflux F160NR Capillary High Flux Dialyzer Single Use recall
Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
Why was Optiflux F160NR Capillary High Flux Dialyzer Single Use recalled?
Potential for external blood leaks from the dialyzer header
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: 18HU06016, 18HU06017, 18HU06018 and 18HU06019
- Product
- Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Quantity
- 9,097 cs x 12 units each
- Distribution
- US Nationwide
- Recall date
- December 26, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)