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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Haeng Lim Seo Won 		see related information
Date Posted January 04, 2008
Recall Number Z-0566-2008
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
Reason for
Recall		 Marketed without 510(k)
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
 
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