International safety notice
Regarding the kit product, an internal investigation revealed that there was a procedural omission due to a partial change in the approval items for manufacturing and sales approval. So, I decided to voluntarily collect it here.
Japan / PMDA Recalls · JPN · Jan 21, 2022
Key facts
| Title | Regarding the kit product, an internal investigation revealed that there was a procedural omission due to a partial change in the approval items for manufacturing and sales approval. So, I decided to voluntarily collect it here. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Names: (1) (2): Single Use Class II Treatment Kit, (3) (4) (5) (6): Single Use Class III Treatment Kit Sales name: (1) Angiokit AI (2) Treatment kit AI (3) Angio kit BI (4) Angio kit BII (5) Surgical kit (6) Ophthalmology kit |
| Manufacturer | Meditech Japan Co., Ltd. |
| Models | 6700293001, 6700558000, 01210118, 01201215, 10210201, 01211019, 01210106, 10191028, 10200430, 10200618, 10200123, 10210412 and 627 more |
| Date | Jan 21, 2022 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 Matching catalog numbers in FDA data
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