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U.S. Department of Health and Human Services

Class 2 Device Recall CONMED(R) ELECTROSURGICAL SAFETY HOLSTER

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  Class 2 Device Recall CONMED(R) ELECTROSURGICAL SAFETY HOLSTER see related information
Date Initiated by Firm December 27, 2012
Date Posted January 24, 2013
Recall Status1 Terminated 3 on May 14, 2018
Recall Number Z-0726-2013
Recall Event ID 63981
510(K)Number K790770  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product CONMED(R) ELECTROSURGICAL SAFETY HOLSTER, Disposable Safety Holster, REF/Catalog No. 137668, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Code Information Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].
Recalling Firm/
Manufacturer		 ConMed Corporation
525 French Road
Utica NY 13502
For Additional Information Contact M. Patricia Cotter
315-624-3533
Manufacturer Reason
for Recall		 ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
FDA Determined
Cause 2		 Equipment maintenance
Action ConMed sent an Urgent Field Safety Notice dated January 7, 2013, and Business Reply Form to all affected customers via USPS Priority Mail. International notices were sent via FedEx International Priority on December 27, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory and complete Attachment II and return it with unused affected product to: ConMed Corporation 525 French Road, Utica, NY 13502 Customer were asked to return Attachment II even if they don't have any affected product. For questions regarding this recall call 315-624-3533.
Quantity in Commerce 313,190 (total for all devices)
Distribution Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Belgium, Colombia, Czech Republic, Dubai, Guatemala, Hong Kong, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay.
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 = GEI and Original Applicant = ASPEN LABORATORIES, INC.
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