Dialyzer Optiflux 160NRe recall
Dialyzer Optiflux 160NRe
Why was Dialyzer Optiflux 160NRe recalled?
Potential for internal blood leaks due to cracked polyurethane
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
UDI NUMBERS: 24HU06011-00840861100149-270630, 24HU06010-00840861100149-270630. Expiration date: 06/30/2027.
- Product
- Dialyzer Optiflux 160NRe
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 5,351 cases (64,212 dialyzers)
- Distribution
- Nationwide Distribution.
- Recall date
- January 15, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)