International safety notice
It has come to light that a product was shipped with a validity period shorter than the period stipulated in the manufacturing and marketing approval. The shelf life of the shipped product is 18 months, which deviates from the drug approval period (more than 3 years). We will carry out a voluntary recall of the product.
Japan / PMDA Recalls · JPN · May 30, 2024
Key facts
| Title | It has come to light that a product was shipped with a validity period shorter than the period stipulated in the manufacturing and marketing approval. The shelf life of the shipped product is 18 months, which deviates from the drug approval period (more than 3 years). We will carry out a voluntary recall of the product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Single-use hand-controlled electrosurgical active electrode Brand name: ESA electrode |
| Manufacturer | Conmed Japan Co., Ltd. |
| Models | 1352246, 1352245, CS-0230-000-00 |
| Date | May 30, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1