Recall Z-0723-2013 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ConMed Corporation
Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 60-7526-001, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
| Date | Jan 24, 2013 (initiated Dec 27, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 quest |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991855 | CONMED STEALTH NON-STICK ACCESSORY ELECTRODE, MODEL 138XXX Conmedcorp, Jun 15, 1999 |