International safety notice
A medical institution has reported that the product is stuck and cannot be unrolled smoothly. According to the results of the investigation at the manufacturing facility, the anti-adhesive treatment may have been insufficient, resulting in the product not being able to be unrolled smoothly to the root. Therefore, it cannot be denied that the product may not be able to be installed or may be damaged during the process. Therefore, we have decided to voluntarily recall all products with the affected lot numbers.
Japan / PMDA Recalls · JPN · Jan 26, 2022
Key facts
| Title | A medical institution has reported that the product is stuck and cannot be unrolled smoothly. According to the results of the investigation at the manufacturing facility, the anti-adhesive treatment may have been insufficient, resulting in the product not being able to be unrolled smoothly to the root. Therefore, it cannot be denied that the product may not be able to be installed or may be damaged during the process. Therefore, we have decided to voluntarily recall all products with the affected lot numbers. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Ultrasonic probe cover for human body orifices Sales name: Okamoto probe cover soft touch regular |
| Manufacturer | Okamoto Co., Ltd. |
| Models | OM-1005, T171220 |
| Date | Jan 26, 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