Z-2183-2012Class II
BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use
JK Products & Services, Inc / initiated 2012-05-07 / Terminated
JK Products & Services, Inc began a recall of BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use on . FDA classified it as Class II and gives the reason as "The Beauty Angel was marketed without a 510k". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-2183-2012
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- JK Products & Services, Inc
- Product
- BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use.
- Product code
- 000
- Reason for recall
- The Beauty Angel was marketed without a 510k.
- FDA root cause
- No Marketing Application
- Action
- JK Products sent a Mandatory Field Correction Notice - Immediate Action Required letter dated February 10, 2012, to all affected customers. The letter identified the product the problem, and the action to be taken by the customer. The firm instructed customers that they would be replacing the operating instructions for the affected product with new ones that meet the requirements defined by the regulatory authorities. Customers were instructed not to make claims that indicate that using the affected product will result in medical or health benefits, or that directly or indirectly imply that the affected product is intended to cure, treat, diagnose or pevent an illness, or disease. Customers were asked to complete the new owner information request on the return post care enclosed and return to the firm. If product was further distributed those accounts should be contacted immediately and should be advised of this Mandatory Field Correction Notice. For questions customers should call 870-935-1130. For questions regarding this recall call 870-268-2702.
- Quantity in commerce
- 598 units
- Distribution
- Worldwide Distribution - USA (nationwide) and Canada
- Product codes and lots
- All Beauty Angel Models and Serial Numbers Part Numbers 80000904301 and 8001110201.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2183-2012 | Class II | Terminated | Voluntary: Firm initiated |
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