Pink Luminous Breast, Breast transilluminator
FDA Recall #Z-2269-2024 — Class II — May 20, 2024
Product Description
Pink Luminous Breast, Breast transilluminator
Reason for Recall
Firm is marketing and distributing the Pink Luminous Breast device without premarket approval
Recalling Firm
Silkprousa LLC — Miami, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2000 devices
Distribution
US Nationwide distribution in the states of WA, RI.
Code Information
Product is not lot coded, all devices are subject
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated