International safety notice
Some lots of "Ospica VACSII" from Ospica AG in Germany (Lot P338820-06)(*) It was discovered that parts different from the regulations were attached to the "balloon part". I received a message.
Japan / PMDA Recalls · JPN · Dec 7, 2021
Key facts
| Title | Some lots of "Ospica VACSII" from Ospica AG in Germany (Lot P338820-06)(*) It was discovered that parts different from the regulations were attached to the "balloon part". I received a message. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Balloon-expandable valvuloplasty catheter Sales name: Ospica VACSII |
| Manufacturer | Heiwa Bussan Co., Ltd. |
| Models | YA0052, P338820-06 |
| Date | Dec 7, 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