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Terminated

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 for use in conjunction with an electrosurgical accessory handpiece for delivery of high frequency electrosurgical current through an accessory electrode for cutting and coagulation at the operative site. The sterile sheaths are intended to cover the electrosurgical handpiece during those typical electrosurgical procedures and reduce the effort necessary to re-sterilize the handpiece between procedures.

FDA Recall Z-1757-2017 · Posted None

Recalling FirmConMed Corporation
Recall StatusTerminated
Product CodeGEI
Date Initiated2017-02-28

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.

Firm 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 [email protected]. For questions regarding this recall call 315-624-3533.

Root Cause

Mixed-up of materials/components

Distribution Pattern

Worldwide Distribution - US (nationwide) Internationally to Australia, Canada, Germany, Italy, UK, Great Britain, and Ireland.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K963088SHEATH, ELECTROSURGICAL PENCILAspen Laboratories, Inc. · 1996-09-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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