International safety notice
A medical institution requested that the tube and lock connector be connected to each other during use regarding Terfusion pump infusion sets. We received quality information that fluid leaked from the tube or the lock connector came off from the tube. As a result of detailed investigation, it was found that the product had not undergone a pre-treatment process to maintain the bonding strength between the tube and lock connector. It turns out that the item was shipped in error. We have decided to carry out a voluntary recall as there is a possibility that some of the shipped products may contain products in a similar condition. Ta.
Japan / PMDA Recalls · JPN · Sep 13, 2023
Key facts
| Title | A medical institution requested that the tube and lock connector be connected to each other during use regarding Terfusion pump infusion sets. We received quality information that fluid leaked from the tube or the lock connector came off from the tube. As a result of detailed investigation, it was found that the product had not undergone a pre-treatment process to maintain the bonding strength between the tube and lock connector. It turns out that the item was shipped in error. We have decided to carry out a voluntary recall as there is a possibility that some of the shipped products may contain products in a similar condition. Ta. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Infusion set for infusion pump Brand name: Terfusion pump infusion set |
| Manufacturer | Terumo Corporation |
| Models | 230408A, 230408D, TI-PJ300L, 230407A, TI-PU300LY |
| Date | Sep 13, 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