International safety notice
A medical facility has reported that the amount of blood collected for some products of this variety and lot is less than the specified amount. The blood can be aspirated as it is sealed and depressurized in advance for the amount of blood to be collected, but as a result of our investigation, we found that the There may be deviations in the assembly process, and some products may not be depressurized as specified immediately after manufacture. As it became clear, we have decided to take steps to voluntarily recall the product.
Japan / PMDA Recalls · JPN · Jun 18, 2021
Key facts
| Title | A medical facility has reported that the amount of blood collected for some products of this variety and lot is less than the specified amount. The blood can be aspirated as it is sealed and depressurized in advance for the amount of blood to be collected, but as a result of our investigation, we found that the There may be deviations in the assembly process, and some products may not be depressurized as specified immediately after manufacture. As it became clear, we have decided to take steps to voluntarily recall the product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Vacuum sealed blood collection tube Brand name: Vacuette blood collection tube |
| Manufacturer | Greiner Japan Co., Ltd. |
| Models | A20123GW, 474321JP |
| Date | Jun 18, 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