International safety notice
This product is used for retransfusion after suctioning and collecting blood from surgical wounds and removing separated tissue pieces and fat. It is a product that When we received a report that a tube was included in the package, an investigation was conducted at an overseas manufacturer, and we found that one lot had been shipped with an incorrect tube. It turned out that they had packed a drain tube with a different diameter. Because the diameter of the tube does not match the actual product, we have decided to carry out a voluntary recall of the affected products.
Japan / PMDA Recalls · JPN · Dec 28, 2022
Key facts
| Title | This product is used for retransfusion after suctioning and collecting blood from surgical wounds and removing separated tissue pieces and fat. It is a product that When we received a report that a tube was included in the package, an investigation was conducted at an overseas manufacturer, and we found that one lot had been shipped with an incorrect tube. It turned out that they had packed a drain tube with a different diameter. Because the diameter of the tube does not match the actual product, we have decided to carry out a voluntary recall of the affected products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Single-use autologous blood collection kit Brand name: CBC-II Blood Conservation System |
| Manufacturer | Japan Striker Co., Ltd. |
| Models | 22090801M, 0225-426-000JP |
| Date | Dec 28, 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