Recall Z-1311-2022— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-1311-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-01

Class II · Terminated

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2022-06-01, terminated 2024-10-07. It names one FDA 510(k) clearance: K192017. Product: NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3. Reason: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological contamination and therefore an increased risk of potential bloodstream infection..

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Terminated
Initiated: 2022-06-01
Terminated: 2024-10-07
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 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3

Reason for recall

The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological contamination and therefore an increased risk of potential bloodstream infection.

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