Events

Recall of Device Recall Torrent" irrigation tubing

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
    64853
  • Event Risk Class
    Class 2
  • Event Number
    Z-1099-2013
  • Event Initiated Date
    2013-03-07
  • Event Date Posted
    2013-04-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117188
  • 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 firm was notified by their customers that there was a water leakage from the white tubing connector.
  • Action
    US Endoscopy Group sent an Urgent Recall Notification letters to their customers. The letter identified the affected product, problem and actions to be taken. They instructed their customers to remove any of the affected products from their inventory and quarantine them. They also requested each customer complete the attached Customer Response Card and return it to US Endoscopy via fax at 1-440-639-4495 or by email at recall@endoscopy.com as soon as possible. For questions contact Customer Service at 1-800-769-8229.

Device

Device Recall Torrent" irrigation tubing
  • Model / Serial
    Product code: 00711560; Lot #'s: 79687, 79688, 79689, 79690, 79691, 79692, 79693, 79694, 79695, 79696 80165, 80166, 80709, 80710, 80711, 80712, 80713, 80714, 80715, 80716, 80717, 80718, 80719. 80720, 80721, 80722, 80723, 81245, 81246, 81247, 81248, 81249, 81250, 81251, 81252, 81253, 81254, 81255, 81256, 81257, 81258, 81259, 81982, 81983, 81984, 81985, 81986, 81987, 81988, 81989, 81990, 81991, 82567, 82568, 82569, 82570, 82938, 82939, 82940, 82941, 82942, 82943, 82944, 82945, 82946, 82947, 82948, 82949, 82950, 82951, 82953, 82954, 82955, 82956, 84615, 84616, 84617, 84618, 84619, 84620, 84979, 84981, 85557, 86026, 86028, 86434, 86435 & 86436.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution - including the states of: AK, AL, AZ, CA, CO, CT, DE, FL, GA, ID, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI & WV.
  • Product Description
    Torrent" irrigation tubing. || Product Usage: The Torrent irrigation system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.
  • 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