Summary
The FDA issued a Class II for Regular Flow Bundle; Model Number: FG-BNDL-PC-REFRF; by DAYE (ANNE'S DAY LTD). Reason: Product lacks 510(k) clearance..
Details
Source
Device Recall
External ID
Z-0388-2026
Action Date
2025-11-05
Status
Ongoing
Category
device
Product Description
Regular Flow Bundle; Model Number: FG-BNDL-PC-REFRF;
Lot/Code Info: Model Number: FG-BNDL-PC-REFRF; UDI-DI: 5060994741582; 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,
Quantity Affected: 3074 packs
Reason for Recall
Product lacks 510(k) clearance.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-17
Company
London, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 284 device recalls issued in the same week, part of 403 device-related FDA actions this month.
DAYE (ANNE'S DAY LTD) has 29 FDA actions in our database, including 29 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DAYE (ANNE'S DAY LTD)) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DAYE (ANNE'S DAY LTD) have FDA actions?
DAYE (ANNE'S DAY LTD) has 29 FDA actions in our database, including 29 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0388-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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