International safety notice
In-house testing of the product confirmed that the endotoxin level exceeded the standard value, so the affected product was We have decided to voluntarily recall the items.
Japan / PMDA Recalls · JPN · Sep 27, 2023
Key facts
| Title | In-house testing of the product confirmed that the endotoxin level exceeded the standard value, so the affected product was We have decided to voluntarily recall the items. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Central circulatory system intravascular ultrasound catheter Brand name: TVC Catheter TVC-C195-42 |
| Manufacturer | Goodman Co., Ltd. |
| Models | TVC-C195-42, DPY230727A, DPY230616A, DPY230421A, DPY230706A, DPY230512A, DPY230407A |
| Date | Sep 27, 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