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, &
FDA device recall Z-2236-2010 · posted 2010-08-18 · Terminated
Recall details
- Recalling firm
- Olympus America Inc.
- Reason for recall
- An investigation of consumer complaints revealed the inability of the snare wire to be retracted into the snare tube after deployment of the snare.
- Action taken
- 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 be directed towards Laura Storms-Tyler at 484-896-5688 or laura.storms-tyler@olympus.com.
- Root cause
- Other
- Status
- Terminated
- Product code
- FDI
- Quantity affected
- 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.
- Date initiated
- 2010-05-03
- Date posted
- 2010-08-18
- Date terminated
- 2013-05-20
- Location
- Center Valley, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OLYMPUS SD SERIES SNARES (K955650) | Olympus America, Inc. | 1996-03-29 |