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U.S. Department of Health and Human Services

Class 2 Device Recall Beauty Angel

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 Class 2 Device Recall Beauty Angelsee related information
Date Initiated by FirmMay 07, 2012
Date PostedAugust 10, 2012
Recall Status1 Terminated 3 on January 07, 2015
Recall NumberZ-2183-2012
Recall Event ID 61855
Product Classification Beauty Angel - Product Code 000
ProductBeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use.
Code Information All Beauty Angel Models and Serial Numbers Part Numbers 80000904301 and 8001110201.
FEI Number 2311923
Recalling Firm/
Manufacturer		 JK Products & Services, Inc
1 Walter Kratz Dr
Jonesboro AR 72401-0609
For Additional Information ContactMr. Lateef Khan
870-268-2702
Manufacturer Reason
for Recall		The Beauty Angel was marketed without a 510k.
FDA Determined
Cause 2		No Marketing Application
ActionJK 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 Commerce598 units
DistributionWorldwide Distribution - USA (nationwide) and Canada
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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