International safety notice
It was discovered that the product had been sterilized at a different sterilization facility than the one listed on the approval letter, so the We have decided to voluntarily recall the products with this lot number.
Japan / PMDA Recalls · JPN · Aug 22, 2022
Key facts
| Title | It was discovered that the product had been sterilized at a different sterilization facility than the one listed on the approval letter, so the We have decided to voluntarily recall the products with this lot number. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Intraoperative ultrasound probe cover Sales name: Navigator probe cover |
| Manufacturer | Sugan Co., Ltd. |
| Models | WP-9003-DRT, 76867, 77571 |
| Date | Aug 22, 2022 |
| 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