Events

Recall of UroSeal Adjustable Endoscopic 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
    69809
  • Event Risk Class
    Class 2
  • Event Number
    Z-0861-2015
  • Event Initiated Date
    2014-10-31
  • Event Date Posted
    2014-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131574
  • 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
    Endoscope and/or accessories - Product Code KOG
  • Reason
    Packaging non-conformance related to the integrity of the sterile pouch seal.
  • Action
    Consignees were notified by phone, e-mail, and an Urgent: US Endoscopy UroSeal Adjustable Valve Recall letter. The letter identified the affected product and the reason for the recall. Customers were asked to remove any affected product from their inventory and quarantine them. Additionally, customers were to complete and return the attached Customer Response Card to Kia Pennington via fax at 1-440-639-4495 or e-mail at recall@usendoscopy.com as soon as possible. The firm contacted customers regarding the RMA instructions and replacement product. Customers were to follow the RMA instructions in order to receive an RMA number and return the affected product. Questions should be directed towards Kia Pennington in Customer Service at 1-800-769-8229.

Device

UroSeal Adjustable Endoscopic Valve
  • Model / Serial
    Lot 1417696
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to the states of FL, MO, OH and WI.
  • Product Description
    UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 || The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5 units per box. || Used to cover the opening to the biopsy/suction channel of an endoscope.
  • 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