Z-0801-2025 Class II Ongoing
FDA device recall Z-0801-2025 was initiated by Fresenius Medical Care Holdings, Inc. on December 5, 2024 and is designated Class II. Reason for recall: Potential for internal blood leaks due to cracked polyurethane The recall status is ongoing. Affected quantity: 5,351 cases (64,212 dialyzers).
Recall Details
- Product Type
- Devices
- Report Date
- January 15, 2025
- Initiation Date
- December 5, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,351 cases (64,212 dialyzers)
Product Description
Dialyzer Optiflux 160NRe
Reason for Recall
Potential for internal blood leaks due to cracked polyurethane
Distribution Pattern
Nationwide Distribution.
Code Information
UDI NUMBERS: 24HU06011-00840861100149-270630, 24HU06010-00840861100149-270630. Expiration date: 06/30/2027.