Recall Z-3102-2011 ยท EZO Urethrotome
Olympus America Inc.
OLYMPUS Pediatric Knives and Resection Electrodes The pediatric knives are intended for use in urethrotomy in pediatric applications. The HF resection electrodes are intended for use in transurethral resection in pediatric applications.
| Date | Aug 31, 2011 (initiated Dec 22, 2010) |
| Status | Terminated |
| Reason | The device sterile package seal shows evidence of being breached or was breached |
| Root cause | Packaging process control |
| Action | Olympus America Inc. sent an "URGENT PRODUCT RECALL" letter dated December 22, 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to check their inventory for the affected product and to destroy or discard, if found. A questionnaire was attached to the letter for customers to complete and return via fax to Olympus at 484-896-7128. Contact the firm at 484-896-5688 for questions regarding this recall. |
| Quantity | 1305 devices |
| Distribution | USA (nationwide) including the states of AL, AR, CA, CO, CT, FL, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OR, TX, VA, VT, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K904939 | FLEXIBLE AND RIGID URETEROTOME SYSTEM Olympus Corp., Jan 7, 1992 |