International safety notice
There is a clamper that has the function of cutting off the blood circuit when an abnormality is detected in the device or the blood circuit. It was discovered that there was a processing defect in the finish of a certain clamp part, so we are voluntarily recalling it.
Japan / PMDA Recalls · JPN · Feb 28, 2024
Key facts
| Title | There is a clamper that has the function of cutting off the blood circuit when an abnormality is detected in the device or the blood circuit. It was discovered that there was a processing defect in the finish of a certain clamp part, so we are voluntarily recalling it. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Device for removing blood cells Sales name: Adamonitor SC |
| Manufacturer | Otsuka Electronics Co., Ltd. |
| Models | 570104, 570160, 570125, 570230, 570221, 570001, 570047, 570132, 570200, 570151, 570080, 570191 |
| Date | Feb 28, 2024 |
| 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