Z-2269-2024 Class II Ongoing
FDA device recall Z-2269-2024 was initiated by Silkprousa LLC on May 20, 2024 and is designated Class II. Reason for recall: Firm is marketing and distributing the Pink Luminous Breast device without premarket approval The recall status is ongoing. Affected quantity: 2000 devices.
Recall Details
- Product Type
- Devices
- Report Date
- July 17, 2024
- Initiation Date
- May 20, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2000 devices
Product Description
Pink Luminous Breast, Breast transilluminator
Reason for Recall
Firm is marketing and distributing the Pink Luminous Breast device without premarket approval
Distribution Pattern
US Nationwide distribution in the states of WA, RI.
Code Information
Product is not lot coded, all devices are subject