Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF;
Reported: November 5, 2025 Initiated: February 17, 2025 #Z-0389-2026
Product Description
Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF;
Reason for Recall
Product lacks 510(k) clearance.
Details
- Recalling Firm
- DAYE (ANNE'S DAY LTD)
- Units Affected
- 3074 packs
- Distribution
- US Nationwide distribution.
- Location
- London, N/A
Frequently Asked Questions
What product was recalled? ▼
Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF;. Recalled by DAYE (ANNE'S DAY LTD). Units affected: 3074 packs.
Why was this product recalled? ▼
Product lacks 510(k) clearance.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 5, 2025. Severity: Moderate. Recall number: Z-0389-2026.
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