FDA-Device2022-07-13Class II
NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
Fresenius Medical Care Holdings, Inc.
Hazard
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.
Sold states
US Nationwide distribution in the states of Texas and Louisiana.
Affected count
3 cases
Manufactured in
920 Winter St Bld 950, N/A, Waltham, MA, United States
Products
NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1311-2022Don't want to check this manually?
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