Events

Recall of Device Recall TUOHY Epidural Needle

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

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
    77842
  • Event Risk Class
    Class 2
  • Event Number
    Z-0089-2018
  • Event Initiated Date
    2017-07-24
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158025
  • 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
    Epidural anesthesia kit - Product Code OGE
  • Reason
    Potential for partially incomplete seal of product, impacting sterility.
  • Action
    Consignees were contacted 07/24/2017 via email and phone, notifying them of the recall. Consignees were asked to contact the recalling firm to report the number of affected product on hand. A second, updated recall notification was sent on 08/04/2017. Instructions included to examine inventory and quarantine any affected product, contact Epimed to arrange return/credit of the affected product, and complete and return the response form.

Device

Device Recall TUOHY Epidural Needle
  • Model / Serial
    Lot No. 12358202; Ref No. 125-2035T.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Domestic: AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, & WA. Foreign: Canada, Czech Republic, Germany ,& Turkey.
  • Product Description
    TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only
  • Manufacturer
    Epimed International

Manufacturer

Epimed International
  • Manufacturer Address
    Epimed International, 13958 Diplomat Dr, Farmers Branch TX 75234-8805
  • Manufacturer Parent Company (2017)
    Epimed International Inc
  • Source
    USFDA