Recall Z-0518-2019— Fresenius Medical Care Renal Therapies Group, LLC

Name: FDA recall Z-0518-2019
Creator: U.S. Food and Drug Administration
Published: 2018-10-09

Class III · Terminated

Class III FDA medical device recall by Fresenius Medical Care Renal Therapies Group, LLC, initiated 2018-10-09, terminated 2021-08-05. It names one FDA 510(k) clearance: K030497. Product: Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis. Reason: Discolored powder has confirmed the presence of a foreign substance.

Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Classification: Class III
Status: Terminated
Initiated: 2018-10-09
Terminated: 2021-08-05
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K030497 — FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIESFresenius Medical Care·cleared 2003-05-20

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

Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis

Reason for recall

Discolored powder has confirmed the presence of a foreign substance

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