International safety notice
When using the circuit from the vendor at a medical institution, a different connector is attached to the circuit and the plasma separator and circuit are connected. There were reports that it was not possible. As a result of the investigation, it was discovered that some of the lots had connectors that were different from the regulations, so a recall was necessary. I decided that it was necessary.
Japan / PMDA Recalls · JPN · Apr 13, 2022
Key facts
| Title | When using the circuit from the vendor at a medical institution, a different connector is attached to the circuit and the plasma separator and circuit are connected. There were reports that it was not possible. As a result of the investigation, it was discovered that some of the lots had connectors that were different from the regulations, so a recall was necessary. I decided that it was necessary. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Blood circuit for plasma separation Brand name: Plasmapheresis therapy circuit |
| Manufacturer | Naniwa Rubber Industry Co., Ltd. |
| Models | 1X2794, 55set |
| Date | Apr 13, 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