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U.S. Department of Health and Human Services

Class 2 Device Recall Haeng Lim Seo Won

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 Class 2 Recall
Haeng Lim Seo Won
see related information
Date Posted January 04, 2008
Recall Status1 Open
Recall Number Z-0566-2008
Recall Event ID 45904
Premarket Notification
510(K) Number
K043506 
Product Classification Needle, Acupuncture, Single Use - Product Code MQX
Product HAENG LIM --Acupunture Needles- PRE-STERILIZED GAMMA-RAY; 100 PKGS (10 NEEDLES/PACKAGE-1,000 needles in each box). Sale Agency HAENG LIM SEO WON #45-9, Gunjang-ri, Ganam-myeon, Yeoju-gun, Kyungki-do, Korea
Code Information All Lot Numbers and Serial Numbers
Recalling Firm/
Manufacturer
Marknew Products
9401 Norwalk Blvd
Santa Fe Springs, California 90670-2927
For Additional Information Contact Tae (Damien) Kim
562-908-5000
Manufacturer Reason
for Recall
Marketed without 510(k)
FDA Determined
Cause 2
PREMARKET APPROVAL: No Marketing Application
Action Marknew Products, LLC, sent an Important Recall Notice to their customers on November 27, 2007, advising them that all Haeng Lim Seo Won Acupuncture Needles that they have received, have not been cleared for distribution in the USA. All customers have been requested to return product back to Marknew Products for credit. A response form was included. If customers have questions concerning this product, they are asked to call 562-908-5000.
Quantity in Commerce 320-380 boxes/100 packages (10 needles/package)
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MQX and Original Applicant = MARKNEW PRODUCTS
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