FDA Device recall Z-1759-2017
Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) car…
- FDA Device
- Class II
- terminated
- Published 2017-04-19
On 2017-04-19 the FDA classified a Class II recall of Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) car… by Conmed, citing 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 th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1759-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-28 |
| Published | 2017-04-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Conmed |
| Distribution | US |
Product
Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 230 VOLTS AC, REF/Catalog Number 7-900-230, Rx Only. There is no problem with the Hyfrecator 2000 Electrosurgical Units. -- ASSEMBLED IN MEXICO -- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502
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.
Identifiers
| code_info | Serial Numbers: 1640179, 15500473, 16090084, 16140185, 16170283, 16250376, 16370476, 16380489, 1640180, 15510474, 16090…Serial Numbers: 1640179, 15500473, 16090084, 16140185, 16170283, 16250376, 16370476, 16380489, 1640180, 15510474, 16090085, 16140186, 16170284, 16250377, 16370477, 16380490, 1640181, 15510475, 16090086, 16140187, 16170285, 16250378, 16370478, 16380491, 1640182, 15510476, 16090087, 16140188, 16170286, 16260379, 16380479, 16380492, 1640183, 15510477, 16090088, 16140189, 16170287, 16260380, 16380480, 16480592, 1640184, 15510478, 16090089, 16140190, 16170288, 16260381, 16380481, 16480593, 1640185, 15510479, 16090090, 16140191, 16170289, 16260382, 16380482, 16480594, 1640186, 15510480, 16090091, 16140192, 16170290, 16260383, 16380483, 16480595, 1640187, 15510481, 16090092, 16140193, 16170291, 16260384, 16380484, 16480596, 1640188, 15510482, 16090093, 16140194, 16170292, 16260385, 16380485, 16480597, 15260015, 15510483, 16090094, 16140195, 16170293, 16260386, 16380486, 16480598, 15260016, 15510484, 16090095, 16140196, 16170294, 16260387, 16380487, 16480599, 15260018, 15510485, 16090096, 161 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1759-2017%22
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