International safety notice
We have received a report from an overseas manufacturer that there may be small holes in the packaging that ensures sterility. determines that the occurrence of infectious diseases cannot be ruled out if products packaged that cannot guarantee sterility are used, and voluntarily We have decided to collect it.
Japan / PMDA Recalls · JPN · Sep 5, 2024
Key facts
| Title | We have received a report from an overseas manufacturer that there may be small holes in the packaging that ensures sterility. determines that the occurrence of infectious diseases cannot be ruled out if products packaged that cannot guarantee sterility are used, and voluntarily We have decided to collect it. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Angioplasty balloon pressurizer Brand name: Monarch Inflation Syringe |
| Manufacturer | Merit Medical Japan Co., Ltd. |
| Models | H2845266, H2739491, H2446311, H2378902, H2770192, H2326018, H2348220, H2790666, H2335950, H2721346, H2838478, H2709628 and 20 more |
| Date | Sep 5, 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