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Terminated

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

FDA Recall Z-0566-2008 · Posted 2008-01-04

Recalling FirmMarknew Products
Recall StatusTerminated
Product CodeMQX
Date Initiated2007-11-28
Date Terminated2012-01-18
Product Quantity320-380 boxes/100 packages (10 needles/package)

Reason for Recall

Marketed without 510(k)

Firm 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.

Root Cause

PMA

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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