FDA Device recall Z-1757-2017
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-1757-2017 |
| 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, 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.
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: 1618320 16020102 16070492 16110883 16171279 16231666 16382087 16402485 16442884 16493284 16…Serial Numbers: 1618320 16020102 16070492 16110883 16171279 16231666 16382087 16402485 16442884 16493284 1618330 16020103 16070493 16110884 16171280 16231667 16382088 16412486 16442885 16493285 13181360 16020104 16070494 16110885 16171281 16231668 16382089 16412487 16442886 16493286 15010013 16020105 16070495 16120886 16171282 16231669 16382090 16412488 16442887 16493287 15070434 16020106 16070496 16120887 16171283 16231670 16382091 16412489 16442888 16493288 15221592 16020107 16070497 16120888 16171284 16231671 16382092 16412490 16442889 16493289 15221593 16020108 16070498 16120889 16171285 16231672 16382093 16412491 16442890 16493290 15221594 16020109 16070499 16120890 16171286 16231673 16382094 16412492 16442891 16493291 15221595 16020110 16070500 16120891 16171287 16231674 16382095 16412493 16442892 16493292 15221596 16020111 16080501 16120892 16171288 16231675 16382096 16412494 16442893 |
|---|
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-1757-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.