International safety notice
Regarding this product, we have received a report from a medical institution that liquid leakage occurred from the gap in the lid at the top of the chamber. Upon investigation by the manufacturer, it was found that the specified amount of chemical was not applied during the chamber welding process of the lot. I have confirmed that it is possible. Since we cannot deny the possibility of liquid leakage due to poor welding, we are conducting a voluntary recall of the affected lots. That's it.
Japan / PMDA Recalls · JPN · Sep 2, 2021
Key facts
| Title | Regarding this product, we have received a report from a medical institution that liquid leakage occurred from the gap in the lid at the top of the chamber. Upon investigation by the manufacturer, it was found that the specified amount of chemical was not applied during the chamber welding process of the lot. I have confirmed that it is possible. Since we cannot deny the possibility of liquid leakage due to poor welding, we are conducting a voluntary recall of the affected lots. That's it. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Dialysis blood circuit set Brand name: Extracorporeal circulation blood circuit for dialysis |
| Manufacturer | Nikkiso Co., Ltd. |
| Models | 21081010, 21081011, 21081012, TX-JB-12 |
| Date | Sep 2, 2021 |
| 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