International safety notice
We have received reports of defects in some products from medical institutions that supply these products. After investigating the issue, we found that some of the products had the same tearing phenomenon as reported in the defect report, so we decided to voluntarily recall the products. did.
Japan / PMDA Recalls · JPN · Sep 12, 2024
Key facts
| Title | We have received reports of defects in some products from medical institutions that supply these products. After investigating the issue, we found that some of the products had the same tearing phenomenon as reported in the defect report, so we decided to voluntarily recall the products. did. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Single use general purpose surgical drape Sales name: Unishield |
| Manufacturer | Nissho Sangyo Co., Ltd. |
| Models | 【20231016，20231223，20240122，20240402，20240416，20240606】, 【20231016，20231110，20231223，20240122，20240416，20240606】, 22108, 22102, 【20231223，20240122，20240306，20240402，20240606】, 22101, 22106, 【20231016，20231223，20230122】, 【20231223，20240402，20240416，20240606，20240626】, 22107 |
| Date | Sep 12, 2024 |
| 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