International safety notice
Regarding this product, we have received information from a customer that the shape of the outer needle base is different. Connectors of new standard products (hereinafter referred to as "new standard products") that comply with ISO 80369-6 in fixed lots of outer needle bases. It has been confirmed that there are defective products that cannot be connected properly to the connector of the old standard product (but can be connected to the connector of the old standard product). Ta.
Japan / PMDA Recalls · JPN · Jan 20, 2023
Key facts
| Title | Regarding this product, we have received information from a customer that the shape of the outer needle base is different. Connectors of new standard products (hereinafter referred to as "new standard products") that comply with ISO 80369-6 in fixed lots of outer needle bases. It has been confirmed that there are defective products that cannot be connected properly to the connector of the old standard product (but can be connected to the connector of the old standard product). Ta. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: epidural needle Brand name: Epimed RX epidural needle |
| Manufacturer | Tokyo Iken Co., Ltd. |
| Models | 108-1416, 121611524, 121611835 |
| Date | Jan 20, 2023 |
| 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