International safety notice
During our in-house process, we confirmed that there were holes in the cover membrane covering the stent of the target product. Considering safety first, we have decided to voluntarily recall the product.
Japan / PMDA Recalls · JPN · Feb 1, 2022
Key facts
| Title | During our in-house process, we confirmed that there were holes in the cover membrane covering the stent of the target product. Considering safety first, we have decided to voluntarily recall the product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Biliary stent Sales name: Covered By Bile Lash Advance |
| Manufacturer | Piolax Medical Device Co., Ltd. |
| Models | 10930B025, 01201A036, 10729A029, 10603B018, 10121A004, 10121A001, 01008B007, 10114A024, 10930B035, 11202A056, 10603B003, 10318A032 and 1315 more |
| Date | Feb 1, 2022 |
| 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