| Date Initiated by Firm | May 20, 2024 |
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| Date Posted | July 05, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2269-2024 |
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| Recall Event ID |
94539 |
| Product Classification |
Transilluminator (diaphanoscope) - Product Code LEK
|
| Product | Pink Luminous Breast, Breast transilluminator |
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| Code Information |
Product is not lot coded, all devices are subject |
Recalling Firm/
Manufacturer |
Silkprousa LLC
3257 Nw 7th Avenue Cir
Miami FL 33127-3313
|
| For Additional Information Contact | Ruth Garcia
305-218-2936 |
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Manufacturer Reason
for Recall | Firm is marketing and distributing the Pink Luminous Breast device without premarket approval |
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FDA Determined
Cause 2 | No Marketing Application |
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| Action | 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. |
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| Quantity in Commerce | 2000 devices |
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| Distribution | US Nationwide distribution in the states of WA, RI. |
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| Total Product Life Cycle | TPLC Device Report |
|---|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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