Recall Z-0658-2019— Fresenius Medical Care Renal Therapies Group, LLC

Name: FDA recall Z-0658-2019
Creator: U.S. Food and Drug Administration
Published: 2018-11-05

Class II · Terminated

Class II FDA medical device recall by Fresenius Medical Care Renal Therapies Group, LLC, initiated 2018-11-05, terminated 2023-04-17. It names 2 FDA 510(k) clearances: K162488, K152367. Product: Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E. Reason: Potential for external blood leaks from the dialyzer header.

Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Classification: Class II
Status: Terminated
Initiated: 2018-11-05
Terminated: 2023-04-17
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K162488 — Optiflux dialyzerFresenius Medical Care North America·cleared 2017-04-06
K152367 — Optiflux dialyzerFresenius Medical Care North America·cleared 2015-10-29

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

Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E

Reason for recall

Potential for external blood leaks from the dialyzer header

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