Recall Z-0801-2025— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-0801-2025
Creator: U.S. Food and Drug Administration
Published: 2024-12-05

Class II · Ongoing

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2024-12-05. It names one FDA 510(k) clearance: K162488. Product: Dialyzer Optiflux 160NRe. Reason: Potential for internal blood leaks due to cracked polyurethane.

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-12-05
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K162488 — Optiflux dialyzerFresenius Medical Care North America·cleared 2017-04-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Dialyzer Optiflux 160NRe

Reason for recall

Potential for internal blood leaks due to cracked polyurethane

Data sourced from openFDA. This site is unofficial and independent of the FDA.