Torrent" irrigation tubing. Product Usage: The Torrent irrigation system (tubing and accessories to accommodate various
FDA device recall Z-1099-2013 · posted 2013-04-11 · Terminated
Recall details
- Recalling firm
- US Endoscopy Group Inc
- Reason for recall
- The firm was notified by their customers that there was a water leakage from the white tubing connector.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OCX
- Quantity affected
- 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, U
- Date initiated
- 2013-03-07
- Date posted
- 2013-04-11
- Date terminated
- 2014-03-20
- Location
- Mentor, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IRRIGATION SYSTEM (K103239) | United States Endoscopy Group, Inc. | 2010-12-30 |