FDA recall Z-0801-2025
Fresenius Medical Care Holdings, Inc. · Class II · device
Product
Dialyzer Optiflux 160NRe
Reason for recall
Potential for internal blood leaks due to cracked polyurethane
Distribution
Nationwide Distribution.
Key facts
- Status
- Ongoing
- Initiation date
- 2024-12-05
- Report date
- 2025-01-15
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Waltham, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0801-2025