Recall Z-1371-2022— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-1371-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-31

Class II · Ongoing

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2022-05-31. It names one FDA 510(k) clearance: K192017. Product: NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2. Reason: Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use.

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-05-31
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K192017 — Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC·cleared 2020-04-24

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

NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2

Reason for recall

Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use

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