Recall Z-1099-2013— US Endoscopy Group Inc

Name: FDA recall Z-1099-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-07

Class II · Terminated

Class II FDA medical device recall by US Endoscopy Group Inc, initiated 2013-03-07, terminated 2014-03-20. It names one FDA 510(k) clearance: K103239. Product: 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.. Reason: The firm was notified by their customers that there was a water leakage from the white tubing connector..

Recalling firm: US Endoscopy Group Inc
Classification: Class II
Status: Terminated
Initiated: 2013-03-07
Terminated: 2014-03-20
Firm location: Mentor, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K103239 — IRRIGATION SYSTEMUnited States Endoscopy Group, Inc.·cleared 2010-12-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

The firm was notified by their customers that there was a water leakage from the white tubing connector.

Data sourced from openFDA. This site is unofficial and independent of the FDA.