DAYE (ANNE'S DAY LTD): Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFA

The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand: DAYE (ANNE'S DAY LTD)
Product: Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO;
Reason / hazard: Product lacks 510(k) clearance.
Classification: Class II
Status: Ongoing
Distribution / sold at: US Nationwide distribution.
Recall initiated: 2025-02-17
Code info: Model Number: FG-BNDL-PC-MM-REFAIO; UDI-DI: 5060994741605; Lot numbers: 20CR0014, 20CS0034, 20CS0037, 20CS0038, 20CS0039, 20CS0040, 20CS0041, CR001597, CR001598, CR001599, CR001616, CR001616NR001893, CR001617, CR001617CS002165, CR001617NR001844ST23/R/3001-0523ADL, CR001617NR001902, CR001619, CR001623, CR001625, CR001625NR001844ST23/R/3001-0523ADL, CR001626, CR001627, CR001629, CR001633, CR001636, CR001638, CR001640, CR001643, CR001645, CR001655, CR001661, CR001662, CR003000, CR003001, CR003002, CR003005, CR003008, CR003009, CR003020, CR003022, CR003027, CR003031, CR003032, CR003038, CS002088, CS002119, CS002120, CS002121, CS002122, CS002143, CS002144, CS002159, CS002164, CS002164NS001653, CS002165, CS002165NS001653, CS002166, CS002166NS001648ST23/M/3001-0223ADL, CS002167, CS002168, CS002169, CS002177, CS002181, CS002183, CS002195, CS002196, CS003005, CS003015, CS003016, CS003022, CS003034, CS003048, CS003049, CS003050, CS003052, CS003053, CS003054, CS003055, CS003057, CS003062, CS003081, CR001615, CR001616CS002163NR001890NS001649, CR001616CS002163NR001892NS001650, CR001616CS002164, CR001617CS002165, CR001655CS002196, CS002163, CS002164, CR001661NR002015, CS003005NS001775, CR003000, CS003005, CS003016, CS003022, CR003000, CR003000, CR003000NR002173, CS003022NS001781,
Product quantity: 3074 packs
Voluntary mandated: Voluntary: Firm initiated
City: London
State: N/A
Country: United Kingdom
Event id: 97718

DAYE (ANNE'S DAY LTD): Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO;