Recall Z-1756-2017
ConMed Corporation · initiated February 28, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 100 VOLTS AC, REF/Catalog Number 7-900-100, Rx Only. There is no problem with the Hyfrecator 2000 Electrosurgical Unit. -- ASSEMBLED IN MEXICO --- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502
Codes / lots: Serial Numbers: 1540139, 15280024, 15420101, 15470153, 15510179, 16010007, 1540144, 15280026, 15420102, 15470161, 15510182, 16010008, 15250002, 15290032, 15430106, 15490169, 15510186, 16010009, 15250004, 15290033, 15430107, 15490170, 15510189, 16010010, 15250005, 15300038, 15430110, 15490172, 15510190, 16430108, 15250006, 15350041, 15430111, 15500173, 15510192, 16430109, 15250007, 15350043, 15430113, 15500174, 16010001, 16430112, 15250008, 15350044, 15430114, 15500175, 16010002, 15260010, 15360054, 15430115, 15500176, 16010003, 15260012, 15360057, 15460140, 15500177, 16010004, 15260013, 15360059, 15460142, 15510178, 16010005, 15280023, 15360060, 15460146, 15510179, 16010006.
Reason for recall
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.
FDA-determined cause: Mixed-up of materials/components
Action taken
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 questions regarding this recall call 315-624-3533.
Details
- Recall number
- Z-1756-2017
- Initiated
- February 28, 2017
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Distribution
- Worldwide Distribution - US (nationwide) Internationally to Australia, Canada, Germany, Italy, UK, Great Britain, and Ireland.
- Recalling firm
- ConMed Corporation, Utica, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1757-2017 Class II | Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in…For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the… | 02/28/2017Terminated |
| Z-1758-2017 Class II | Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in…For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the… | 02/28/2017Terminated |
| Z-1759-2017 Class II | Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in…For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the… | 02/28/2017Terminated |
| Z-1760-2017 Class II | HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx ONLY, STERILE, Single…For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the… | 02/28/2017Terminated |