International safety notice
An investigation by overseas manufacturers revealed that certain production lots of the products manufactured between September 2022 and March 2023 were A review of manufacturing records revealed that some products had been sterilized with gamma radiation doses exceeding the specified range. For this reason, we have decided to voluntarily recall the affected products.
Japan / PMDA Recalls · JPN · Dec 21, 2023
Key facts
| Title | An investigation by overseas manufacturers revealed that certain production lots of the products manufactured between September 2022 and March 2023 were A review of manufacturing records revealed that some products had been sterilized with gamma radiation doses exceeding the specified range. For this reason, we have decided to voluntarily recall the affected products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Sterile Silk Suture Sales name: Sofsilk |
| Manufacturer | Covidien Japan Co., Ltd. |
| Models | GS453-2, D2D1576RY |
| Date | Dec 21, 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