FDA-Device2025-11-05Class II
Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;
DAYE (ANNE'S DAY LTD)
Hazard
Product lacks 510(k) clearance.
Sold states
US Nationwide distribution.
Affected count
3074 packs
Manufactured in
Biscuit Factory Business Complex, 100 Drummond Road, London, N/A, United Kingdom
Products
Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0407-2026Don't want to check this manually?
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