Recall Z-0566-2008 ยท MQX Needle, Acupuncture, Single Use
Marknew Products
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
| Date | Jan 4, 2008 (initiated Nov 28, 2007) |
| Status | Terminated |
| Reason | Marketed without 510(k) |
| Root cause | 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 | 320-380 boxes/100 packages (10 needles/package) |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.