International safety notice
A product is shipped from an overseas manufacturer with a different product code than the actual product specifications displayed on the packaging, and the product is different from the original storage plan. We have received reports that a product with the following specifications has been used in surgery. As a result of investigating the cause, there may be a mismatch between the product code and product specifications of products manufactured under specific manufacturing conditions. We have decided to voluntarily recall all products manufactured under these manufacturing conditions.
Japan / PMDA Recalls · JPN · Jan 16, 2023
Key facts
| Title | A product is shipped from an overseas manufacturer with a different product code than the actual product specifications displayed on the packaging, and the product is different from the original storage plan. We have received reports that a product with the following specifications has been used in surgery. As a result of investigating the cause, there may be a mismatch between the product code and product specifications of products manufactured under specific manufacturing conditions. We have decided to voluntarily recall all products manufactured under these manufacturing conditions. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Aortic stent graft Brand name: RelayPro Thoracic Stent Graft System |
| Manufacturer | Terumo Corporation |
| Models | 2201200099, 2203020201, 2201220095, AR-N4020436, 2201310004, 2206140192, 2202160141, AR-N3016430, AR-N3815438, AR-N2816424, AR-N3420930, AR-N2810428 |
| Date | Jan 16, 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