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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 Device Recall Haeng Lim Seo Won see related information
Date Initiated by Firm November 28, 2007
Date Posted January 04, 2008
Recall Status1 Terminated 3 on January 18, 2012
Recall Number Z-0566-2008
Recall Event ID 45904
510(K)Number K043506:  
Product Classification Accupuncture Needles - 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 CA 90670-2927
For Additional Information Contact Tae (Damien) Kim
562-908-5000
Manufacturer Reason
for Recall		 Marketed without 510(k)
FDA Determined
Cause 2		 PMA
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 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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