Events

Recall of Device Recall Haeng Lim Seo Won

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Marknew Products.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    45904
  • Event Risk Class
    Class 2
  • Event Number
    Z-0566-2008
  • Event Initiated Date
    2007-11-28
  • Event Date Posted
    2008-01-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66452
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Accupuncture Needles - Product Code MQX
  • Reason
    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.

Device

Device Recall Haeng Lim Seo Won
  • Model / Serial
    All Lot Numbers and Serial Numbers
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    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
  • Manufacturer
    Marknew Products

Manufacturer

Marknew Products
  • Manufacturer Address
    Marknew Products, 9401 Norwalk Blvd, Santa Fe Springs CA 90670-2927
  • Manufacturer Parent Company (2017)
    Marknew Products
  • Source
    USFDA