Recall Z-1757-2017 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ConMed Corporation
Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 115 VOLTS AC, REF/Catalog Number 7-900-115, Rx Only . There is no problem with the Hyfrecator 2000 Electrosurgical Units. -- ASSEMBLED IN MEXICO --- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502 The Hyfrecator 2000 Electrosurgical Unit is indicated
| Date | Feb 28, 2017 |
| Status | Terminated |
| Reason | For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to use a non-sterile sheath as if it were sterile. |
| Root cause | Mixed-up of materials/components |
| Action | ConMed sent an URGENT: MEDICAL DEVICE RECALL Notices (dated 2/28/2017)to all affected US customers by USPS First Class Mail. International letters are in the process of translation and are scheduled to be sent by March 15, 2017. Customers were instructed to review their inventory for any of the affected product and were asked to complete the business reply form and return it to ConMed Corporation, 525 French Road, Utica, New York 13502. Customers with questions or requests should contact the Field Action Support Team at 1-800-448-6506, fax to 315-624-3225, or email hyfr2000@conmed.com. For |
| Distribution | Worldwide Distribution - US (nationwide) Internationally to Australia, Canada, Germany, Italy, UK, Great Britain, and Ireland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963088 | SHEATH, ELECTROSURGICAL PENCIL Aspen Laboratories, Inc., Sep 13, 1996 |