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Class 2 Device Recall Haeng Lim Seo Won |
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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:
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Product Classification |
Accupuncture Needles - Product Code MQX
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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
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For Additional Information Contact |
Tae (Damien) Kim 562-908-5000
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Manufacturer Reason for Recall |
Marketed without 510(k)
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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
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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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