International safety notice
We have been informed by an overseas manufacturer that the plunger of this product may come off the barrel. Since we cannot deny that the product is contaminated, we have decided to carry out a voluntary recall of the affected products.
Japan / PMDA Recalls · JPN · Jun 15, 2021
Key facts
| Title | We have been informed by an overseas manufacturer that the plunger of this product may come off the barrel. Since we cannot deny that the product is contaminated, we have decided to carry out a voluntary recall of the affected products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Angioplasty balloon pressurizer Sales name: Merit Basics Alpha |
| Manufacturer | Merit Medical Japan Co., Ltd. |
| Models | H1966485, IN3130, H1896261 |
| Date | Jun 15, 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