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.
FDA Recall Z-1099-2013 · Posted 2013-04-11
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Recalling FirmUS Endoscopy Group Inc
Recall StatusTerminated
Product CodeOCX
Date Initiated2013-03-07
Date Terminated2014-03-20
Product Quantity21,189 units
Reason for Recall
The firm was notified by their customers that there was a water leakage from the white tubing connector.
Firm 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 [email protected] as soon as possible. For questions contact Customer Service at 1-800-769-8229.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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