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.

Fresenius Medical Care Holdings, Inc. Medical Device Recall: Dialyzer Optiflux 160NRe | SafeCheck