Recall Z-1106-2014— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-1106-2014
Creator: U.S. Food and Drug Administration
Published: 2014-02-04

Class II · Terminated

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2014-02-04, terminated 2021-05-18. It names one FDA 510(k) clearance: K043244. Product: Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E. Single Use acute or chronic hemanalysis treatment.. Reason: Dialysate Port Leak During Priming of the Dialyzers.

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-02-04
Terminated: 2021-05-18
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K043244 — FRESENIUS OPTIFLUX F20NR, FF18NR, F16NRFresenius Medical Care North America·cleared 2004-12-20

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 F18Nre Flux Dialyzers; Product Number: 0500308E. Single Use acute or chronic hemanalysis treatment.

Reason for recall

Dialysate Port Leak During Priming of the Dialyzers

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