Class II

Medical Device Recall: Dialyzer Optiflux 160NRe

Fresenius Medical Care Holdings, Inc. · December 5, 2024

Reason for Recall

Potential for internal blood leaks due to cracked polyurethane

Distribution

Nationwide Distribution.

States Affected

NATIONWIDE

Quantity Affected

5,351 cases (64,212 dialyzers)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0801-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.