Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
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
FDA enforcement reports joined to recall event Z-2183-2012
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2183-2012Class IITerminatedVoluntary: Firm initiated