Events

Recall of Device Recall Velocity Biopsy Valve

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
    71336
  • Event Risk Class
    Class 2
  • Event Number
    Z-1943-2015
  • Event Initiated Date
    2015-02-17
  • Event Date Posted
    2015-07-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137329
  • 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 irrigation/suction system - Product Code OCX
  • Reason
    The company has received reports of structural non conformance at the connection between the valve body and the irrigation tube, resulting in separation of the components during use.
  • Action
    US Endoscopy sent an Urgent Recall Notification Letter dated to their customers. The letter identified the affected product, problem and actions to be taken. US Endoscopy requests that their customers: 1. Remove all unused affected Velocity Biopsy Valves from your inventory. 2. Complete the attached Customer Response Card and return to the attention of Kia Pennington, via fax 1-440-639-4495 or email kpenning@usendoscopy.com. 3. Mark the shipping container with code: RMA xxxxxxxx QIF, and return the product to US Endoscopy via Fed Ex Account #293799547. For questions contact Kia Pennington in Customer Service at 1-800-769-8226.

Device

Device Recall Velocity Biopsy Valve
  • Model / Serial
    M/N: 00711140; Lot #'s: 1401267, 1404503, 1408953, 1413362, 1417521, 1420739, 1422288, 1422747, 1424014, and 1500443.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of: CA, CO, IA, MA, OH, TX & WV and the countries of: Brazil, Costa Rica, Croatia, Czech Republic, Egypt, France, Germany, India, Indonesia, Italy, Latvia, Lithuania, Philippines, Poland, Romania, Russian Federation, Slovenia & South Africa.
  • Product Description
    Velocity" Biopsy Valve, 25 units per box, || Product Usage: || The disposable Velocity biopsy valve is used to cover the opening of the biopsy inlet port of a flexible gastrointestinal endoscope. The Velocity biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation, and minimizes leakage of biomaterial from the accessory port throughout the gastrointestinal endoscopic procedure. The Velocity biopsy valve provides a connection for irrigation through the Velocity irrigation pump.
  • 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