Events

Recall of Device Recall Trident Endoscopic Ultrasonic Aspiration Needle (FNA)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Micro-Tech (Nanjing) Co., Ltd..

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
    79911
  • Event Risk Class
    Class 2
  • Event Number
    Z-1878-2018
  • Event Initiated Date
    2018-03-12
  • 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=163919
  • 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
    Endoscopic ultrasound system, gastroenterology-urology - Product Code ODG
  • Reason
    The combination of the firmness of the mass, the potential endoscope and elevator position combined with the force required to penetrate the mass may contribute to the breakage of the needle in the human body, which could cause injury.
  • Action
    The firm emailed the distributor on March 12, 2018. (initial consignee). The consignee has been requested to return all products to the Manufacturer (Micro-Tech Nanjing).

Device

Device Recall Trident Endoscopic Ultrasonic Aspiration Needle (FNA)
  • Model / Serial
    Identifier EUS-22-0-N UPN ES34601 M171226172
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US distribution to one distributor in MI.
  • Product Description
    Trident Endoscopic Ultrasonic Aspiration Needle (FNA)
  • Manufacturer
    Micro-Tech (Nanjing) Co., Ltd.

Manufacturer

Micro-Tech (Nanjing) Co., Ltd.
  • Manufacturer Address
    Micro-Tech (Nanjing) Co., Ltd., High Tech, NO. 10 Gaoke Third Road Nanjing National, Nanjing China
  • Manufacturer Parent Company (2017)
    Micro-Tech (Nanjing) Co. Ltd.
  • Source
    USFDA