Sterile Handpiece Sheaths recalled over sterility concerns

Recall date

February 28, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

ConMed Corporation recalls Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosur…

Recall number

Z-1758-2017

FDA classification

Class II

Brand / firm

ConMed Corporation

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons , 220 VOLTS AC, REF/Catalog Number 7-900-220, Rx Only, There is no problem with the Hyfrecator 2000 Electrosurgical Units --- ASSEMBLED IN MEXICO -- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502 ---