FDA-Device2013-04-17Class II
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.
US Endoscopy Group Inc
Hazard
The firm was notified by their customers that there was a water leakage from the white tubing connector.
Sold states
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.
Affected count
21,189 units
Manufactured in
5976 Heisley Rd, Mentor, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1099-2013Don't want to check this manually?
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