Recall Z-2236-2010 ยท FDI Snare, Flexible
Olympus America Inc.
Olympus SD Snares, Reusable Electrosurgical Snares. Models: SD-9L/U-1, SD-11L/U-1, SD-12L/U-1, SD-13L/U-1, SD-13L/U-1, & SD-16L/U-1. Snare tube model numbers: MAJ-13 and MAJ-15. To be used with Olympus endoscopes to electrosurgically resect tissue within the digestive tract.
| Date | Aug 18, 2010 (initiated May 3, 2010) |
| Status | Terminated |
| Reason | An investigation of consumer complaints revealed the inability of the snare wire to be retracted into the snare tube after deployment of the snare. |
| Root cause | Other |
| Action | Firm initiated this recall following investigation of customer complaints regarding the inability of the snare wire to be retracted into the snare tube. Customers were notified via certified mail, an Urgent: Medical: Device Recall letter issued on May 4, 2010. The letter identified the affected product and the reason for the recall. Customers were instructed to inspect their inventory and identify the affected product. Customers are to remove from use any identified inventory, quarantine, and discard them. Customers should contact the firm to obtain replacement products. Questions should |
| Quantity | 108 units |
| Distribution | Nationwide Distribution -- AR, CA, CO, CT, DC, FL, GA, IN, KS, LA, MD, MO, NC, NY, OH, PA, SC, TN, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955650 | OLYMPUS SD SERIES SNARES Olympus America, Inc., Mar 29, 1996 |