Recall Z-0296-2016— Fresenius Medical Care Renal Therapies Group, LLC

Name: FDA recall Z-0296-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-23

Class II · Terminated

Class II FDA medical device recall by Fresenius Medical Care Renal Therapies Group, LLC, initiated 2015-10-23, terminated 2021-03-02. It names one FDA 510(k) clearance: K131611. Product: Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075. For Use in the Preparation of acid concentrate for hemodialysis.. Reason: Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire..

Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Classification: Class II
Status: Terminated
Initiated: 2015-10-23
Terminated: 2021-03-02
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K131611 — FRESENIUS DRY ACID DISSOLUTION UNITSFresenius Medical Care North America·cleared 2013-08-29

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

Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075. For Use in the Preparation of acid concentrate for hemodialysis.

Reason for recall

Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire.

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