Three month regular flow bundles recalled for lacking 510k clearance
Daye is recalling 3,074 packs of its Initiation 3 Month Regular Flow Bundle because the product lacks 510(k) clearance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites the absence of 510(k) clearance rather than any identified defect or reported harm.
Plain-English summary
The Initiation 3 Month Regular Flow Bundle, model FG-BNDL-PC-MM-IBRF, from Daye (Anne's Day Ltd), is being recalled because the product lacks 510(k) clearance.
The recall covers 3,074 packs carrying UDI-DI 5060994741650, across lots including 20CR0014, 20CS0034, 20CS0037 and 20CS0038. The product was distributed nationwide in the United States. The FDA has classified the action as Class II.
The enforcement record describes a missing premarket clearance rather than an identified defect, and reports no injuries.
Anyone holding the product should follow the firm's instructions.
The recalled product
- Product
- Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;
- Manufacturer
- DAYE (ANNE'S DAY LTD)
- Affected units
- 3,074
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Number: FG-BNDL-PC-MM-IBRF
- UDI-DI: 5060994741650
- Lot numbers: 20CR0014
- 20CS0034
- 20CS0037
- 20CS0038
- 20CS0039
- 20CS0040
- 20CS0041
- CR001597
- CR001598
- CR001599
- CR001616
- CR001616NR001893
- CR001617
- CR001617CS002165
- CR001617NR001844ST23/R/3001-0523ADL
- CR001617NR001902
- CR001619
- CR001623
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 29 recalled by DAYE (ANNE'S DAY LTD) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 29 products in this recall →Related recalls
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