Pink Luminous Breast, Breast transilluminator
This recall is currently active, issued July 5, 2024. It was issued by Silkprousa Llc.
- Company
- Silkprousa Llc
- Recall Initiated
- May 20, 2024
- Posted
- July 5, 2024
- Recall Number
- Z-2269-2024
- Quantity
- 2000 devices
- Firm Location
- Miami, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Firm is marketing and distributing the Pink Luminous Breast device without premarket approval
Distribution
US Nationwide distribution in the states of WA, RI.
Lot / Code Info
Product is not lot coded, all devices are subject
Root Cause
No Marketing Application
Action Taken
SilkProUSA issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 05/16/2024 via FedEx air. The notice explained the issue, the potential risk to health, and requested the consignee quarantine all inventory and notify those to whom they distributed the product. The firm is seeking the return of the affected product.