International safety notice
Replacement kit for bumper button type 28Fr of "BSC Gastrostomy System (Microvasive Button)" In some lots, a fistula measure for 18Fr/24Fr was not included in the package when it should have included a fistula measure for 28Fr. As a result, we have decided to voluntarily recall certain lots of the affected products.
Japan / PMDA Recalls · JPN · Dec 19, 2023
Key facts
| Title | Replacement kit for bumper button type 28Fr of "BSC Gastrostomy System (Microvasive Button)" In some lots, a fistula measure for 18Fr/24Fr was not included in the package when it should have included a fistula measure for 28Fr. As a result, we have decided to voluntarily recall certain lots of the affected products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Long-term use enteral feeding kit Brand name: BSC Gastrostomy System |
| Manufacturer | Boston Scientific Japan Co., Ltd. |
| Models | 31221751, 31761882, 32409573, M00509500, M00509510, 31073152 |
| Date | Dec 19, 2023 |
| 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