Recall Z-1324-2016— Fresenius Medical Care Renal Therapies Group, LLC

Name: FDA recall Z-1324-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-26

Class II · Terminated

Class II FDA medical device recall by Fresenius Medical Care Renal Therapies Group, LLC, initiated 2016-02-26, terminated 2017-06-26. It names one FDA 510(k) clearance: K874872. Product: Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis. Reason: Dialyzer header leak due to possible improper torque.

Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Classification: Class II
Status: Terminated
Initiated: 2016-02-26
Terminated: 2017-06-26
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K874872 — FRESENIUS HEMOFLOW F3, F4, F5, F7Seratronics, Inc.·cleared 1988-02-19

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

Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis

Reason for recall

Dialyzer header leak due to possible improper torque

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