Recall Z-0942-2021— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-0942-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-17

Class II · Terminated

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2020-12-17, terminated 2023-01-05. It names one FDA 510(k) clearance: K070177. Product: Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9. Reason: Bottles Missing Product Label.

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-12-17
Terminated: 2023-01-05
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K070177 — FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIESFresenius Medical Care North America·cleared 2007-03-29

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 Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9

Reason for recall

Bottles Missing Product Label

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