ConMed Corporation Recall: HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx
ConMed Corporation Recall: HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: ConMed Corporation; Product: HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx ONLY, STERILE, Single Patient Use -- CONMED CORPORATION,
| Recalling firm | ConMed Corporation |
|---|---|
| Product | HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx ONLY, STERILE, Single Patient Use -- CONMED CORPORATION, 525 FRENCH ROAD UTICA, NY 13502. --- There is no problem with the Hyfrecator 2000 Electrosurgical Units or with cases of P/N 7-796-19 sold in cases as P/N 7-796-19BX or P/N 7-796-19CS. |
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution - US (nationwide) Internationally to Australia, Canada, Germany, Italy, UK, Great Britain, and Ireland. |
| Recall initiated | 20170228 |
| Recall number | Z-1760-2017 |
| Category | device |
| State | NY |
| Country | United States |
$29/mo
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