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.
FDA Recall Z-3102-2011 · Posted 2011-08-31
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Recalling FirmOlympus America Inc.
Recall StatusTerminated
Product CodeEZO
Date Initiated2010-12-22
Date Terminated2012-09-28
Product Quantity1305 devices
Reason for Recall
The device sterile package seal shows evidence of being breached or was breached
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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