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U.S. Department of Health and Human Services

Class 2 Device Recall Torrent" irrigation tubing

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 Class 2 Recall
Torrent" irrigation tubing
see related information
Date Posted April 11, 2013
Recall Status1 Terminated on March 20, 2014
Recall Number Z-1099-2013
Recall Event ID 64853
Premarket Notification
510(K) Number
K103239 
Product Classification Endoscopic Irrigation/Suction System - Product Code OCX
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.
Code Information 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.
Recalling Firm/
Manufacturer
US Endoscopy Group Inc
5976 Heisley Rd
Mentor, Ohio 44060-1873
For Additional Information Contact Melanie Otto
800-769-8229 Ext. 314
Manufacturer Reason
for Recall
The firm was notified by their customers that there was a water leakage from the white tubing connector.
FDA Determined
Cause 2
DESIGN: Device Design
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.
Quantity in Commerce 21,189 units
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = OCX and Original Applicant = UNITED STATES ENDOSCOPY GROUP, INC.
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