International safety notice
Regarding Jelco I.V. Catheter II, which we manufacture and sell, we receive a specific lot of this product from an overseas manufacturer. However, it was discovered that there was a possibility of fluid leakage at the catheter insertion site due to a manufacturing defect. We have received notification that a voluntary recall will be conducted regarding the following items. We have decided to voluntarily recall the affected products in consideration of the impact on health and patients, as well as compliance with laws and regulations.
Japan / PMDA Recalls · JPN · Sep 20, 2023
Key facts
| Title | Regarding Jelco I.V. Catheter II, which we manufacture and sell, we receive a specific lot of this product from an overseas manufacturer. However, it was discovered that there was a possibility of fluid leakage at the catheter insertion site due to a manufacturing defect. We have received notification that a voluntary recall will be conducted regarding the following items. We have decided to voluntarily recall the affected products in consideration of the impact on health and patients, as well as compliance with laws and regulations. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Sterile plastic cannula puncture needle Brand name: Jelco I.V. Catheter II |
| Manufacturer | Smith Medical Japan Co., Ltd. |
| Models | 4306641, 18520, 4306607 |
| Date | Sep 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