International safety notice
As a result of an investigation at an overseas manufacturer, we found that Bio-Medicus N, an auxiliary product for BioMedicus NextGen cannula (uncoated). The extGen Insertion Kit includes two products (Adult Femoral Vein Insertion Kit: Model Number 96551, Small It was discovered that the product label for the infant arterial/venous insertion kit (model number 96553) had been affixed incorrectly. did. Insertion kit (model number 96553) is subject to a voluntary recall as the legal display label is affixed to it. I decided to do it.
Japan / PMDA Recalls · JPN · Sep 14, 2021
Key facts
| Title | As a result of an investigation at an overseas manufacturer, we found that Bio-Medicus N, an auxiliary product for BioMedicus NextGen cannula (uncoated). The extGen Insertion Kit includes two products (Adult Femoral Vein Insertion Kit: Model Number 96551, Small It was discovered that the product label for the infant arterial/venous insertion kit (model number 96553) had been affixed incorrectly. did. Insertion kit (model number 96553) is subject to a voluntary recall as the legal display label is affixed to it. I decided to do it. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: central circulatory system arteriovenous cannula Brand name: BioMedicus NextGen cannula (uncoated) |
| Manufacturer | Japan Medtronic Co., Ltd. |
| Models | 96553, 220719040 |
| Date | Sep 14, 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