FDA Medical devices recall ·
Dialyzer Optiflux 160NRe recall
- Recall number
- Z-0801-2025
- Date
- (initiated December 5, 2024)
- Company / brand
- Fresenius Medical Care Holdings, Inc.
920 Winter St Bld 920, Waltham, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 5,351 cases (64,212 dialyzers)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Dialyzer Optiflux 160NRe
Why was it recalled?
Potential for internal blood leaks due to cracked polyurethane
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI NUMBERS: 24HU06011-00840861100149-270630, 24HU06010-00840861100149-270630. Expiration date: 06/30/2027.
Distribution
Nationwide Distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0801-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.