FDA-Device2023-12-13Class II
Stay Safe Cap
Hazard
Updating the labeling to include additional warnings and contraindications for potential side effects.
Sold states
US Nationwide distribution.
Affected count
18,236,160 eaches
Manufactured in
920 Winter St Bld 920, Waltham, MA, United States
Products
Stay Safe Cap
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0507-2024More Fresenius Medical Care Holdings, Inc. recalls
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