International safety notice
This product consists of a cannula and an obturator, and when used in combination, A medical device that creates a working channel by puncturing a body cavity. We have received reports from medical institutions of cases where the cannula was damaged while this product was in place. Therefore, we have decided to carry out a voluntary recall of the affected products.
Japan / PMDA Recalls · JPN · Nov 12, 2021
Key facts
| Title | This product consists of a cannula and an obturator, and when used in combination, A medical device that creates a working channel by puncturing a body cavity. We have received reports from medical institutions of cases where the cannula was damaged while this product was in place. Therefore, we have decided to carry out a voluntary recall of the affected products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Single Use Trocar Sleeve Sales name: Unimax Trocker System |
| Manufacturer | JSS Co., Ltd. |
| Models | 8631803014, 8631705014, 6631902071, 8631703184, 8631706198, 6632003069, 6631910001, 6632001024, 8631805194, 6632007028, 8631706177, 8631705015 and 59 more |
| Date | Nov 12, 2021 |
| 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