Silkprousa LLC: Device Recall
Recall #Z-2269-2024 · 05/20/2024
Class II: Risk
Recall Details
- Recall Number
- Z-2269-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Silkprousa LLC
- Status
- Ongoing
- Date Initiated
- 05/20/2024
- Location
- Miami, FL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2000 devices
Reason for Recall
Firm is marketing and distributing the Pink Luminous Breast device without premarket approval
Product Description
Pink Luminous Breast, Breast transilluminator
Distribution Pattern
US Nationwide distribution in the states of WA, RI.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.