International safety notice
The raw materials used for the tip of the delivery sheath of this product were shipped using specifications that differ from those approved. As a result, we have decided to carry out a voluntary recall of products with specific lot numbers.
Japan / PMDA Recalls · JPN · Feb 28, 2024
Key facts
| Title | The raw materials used for the tip of the delivery sheath of this product were shipped using specifications that differ from those approved. As a result, we have decided to carry out a voluntary recall of products with specific lot numbers. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Biliary stent Brand name: Kawasumi Duckbill Biliary Stent |
| Manufacturer | SB Kawasumi Co., Ltd. |
| Models | 221024, 220926, 221121, 231120, L-0806FV, 220725, 211115, 230220, 211018, L-0807FV, 230925, 230724 and 25 more |
| Date | Feb 28, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 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