OLYMPUS Pediatric Knives and Resection Electrodes The pediatric knives are intended for use in urethrotomy in pediatric
FDA device recall Z-3102-2011 · posted 2011-08-31 · Terminated
Recall details
- Recalling firm
- Olympus America Inc.
- Reason for recall
- The device sterile package seal shows evidence of being breached or was breached
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- EZO
- Quantity affected
- 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.
- Date initiated
- 2010-12-22
- Date posted
- 2011-08-31
- Date terminated
- 2012-09-28
- 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 |
|---|---|---|
| FLEXIBLE AND RIGID URETEROTOME SYSTEM (K904939) | Olympus Corp. | 1992-01-07 |