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U.S. Department of Health and Human Services

Class 2 Device Recall OLYMPUS Pediatric Knives and Resection Electrodes

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  Class 2 Device Recall OLYMPUS Pediatric Knives and Resection Electrodes see related information
Date Initiated by Firm December 22, 2010
Date Posted August 31, 2011
Recall Status1 Terminated 3 on September 28, 2012
Recall Number Z-3102-2011
Recall Event ID 57590
510(K)Number K904939  
Product Classification Urethrotome - Product Code EZO
Product 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.
Code Information All lot numbers of Pediatric knives: Model numbers A37008A, A37009A, A37010A and Pediatric HF resection electrodes: Model numbers A37011A, A37012A, A37013A.
Recalling Firm/
Manufacturer		 Olympus America Inc.
3500 Corporate Pkwy.
P.O. Box 610
Center Valley PA 18034-0610
For Additional Information Contact Laura Storms-Tyler
484-896-5688
Manufacturer Reason
for Recall		 The device sterile package seal shows evidence of being breached or was breached
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = EZO and Original Applicant = OLYMPUS CORP.
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