Events

Recall of Device Recall Histolock Resection Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by US Endoscopy Group Inc.

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
    71987
  • Event Risk Class
    Class 2
  • Event Number
    Z-0001-2016
  • Event Initiated Date
    2015-07-14
  • Event Date Posted
    2015-10-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139535
  • 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
    Snare, flexible - Product Code FDI
  • Reason
    The company has determined the sterility cannot be assured for the affected lot.
  • Action
    The firm, US Endoscopy, sent an "URGENT: HISTOLOCK" RESECTION DEVICE RECALL" letter and response form to their customers on July 14, 2015. The letter described the product, problem and action to be taken. The customers were instructed to complete the response form and return to your US Endoscopy Product Specialist and retain a copy of the letter for your records. If you have any questions, contact Sr. Manager, Reg. Affairs & Quality Compliance at 440-358-6251 or email at: ccochara@usendoscopy.com.

Device

Device Recall Histolock Resection Device
  • Model / Serial
    M/N: 00711117; Lot #: 1505956
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to states of: AL, AR, CA, IL, IN, MS, OH, OK & TN.
  • Product Description
    Histolock Resection Device, US Endoscopy. || An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.
  • Manufacturer
    US Endoscopy Group Inc

Manufacturer

US Endoscopy Group Inc
  • Manufacturer Address
    US Endoscopy Group Inc, 5976 Heisley Rd, Mentor OH 44060-1873
  • Manufacturer Parent Company (2017)
    Steris Plc
  • Source
    USFDA