International safety notice
If you start blood collection after changing the blood collection amount that can be set for each blood bag type, the amount of blood remaining to be collected may be small immediately after the start. Although the actual amount of blood drawn will be properly set as per the settings, the actual amount of blood drawn will be We have confirmed an issue where the amount of blood collected is displayed differently. It has been discovered that the settings of variables related to the display of amounts were inappropriate. We have decided to carry out a new voluntary recall.
Japan / PMDA Recalls · JPN · Jul 20, 2023
Key facts
| Title | If you start blood collection after changing the blood collection amount that can be set for each blood bag type, the amount of blood remaining to be collected may be small immediately after the start. Although the actual amount of blood drawn will be properly set as per the settings, the actual amount of blood drawn will be We have confirmed an issue where the amount of blood collected is displayed differently. It has been discovered that the settings of variables related to the display of amounts were inappropriate. We have decided to carry out a new voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Negative pressure blood collection device for blood bags Sales name: Hemoquick AC-187 |
| Manufacturer | Cosmic EM Co., Ltd. |
| Models | 2210001, 2209001, 2306010, 2205001, 2303001, 2208007, 2209005, 2304020, 2301001, 2211001, 2210005, 2208001 and 11 more |
| Date | Jul 20, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers in FDA data
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