International safety notice
A domestic medical institution reported that when the product was disconnected from the infusion set, liquid was leaking from the top of the product. We received the report and investigated. It was discovered that when connected to a male connector such as an infusion set, the seal could not be maintained and leakage occurred. We have decided to carry out a voluntary recall as some of the shipped products may contain products in a similar condition. did.
Japan / PMDA Recalls · JPN · Dec 12, 2024
Key facts
| Title | A domestic medical institution reported that when the product was disconnected from the infusion set, liquid was leaking from the top of the product. We received the report and investigated. It was discovered that when connected to a male connector such as an infusion set, the seal could not be maintained and leakage occurred. We have decided to carry out a voluntary recall as some of the shipped products may contain products in a similar condition. did. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Closed drug transfer system Brand name: Chemosafelock |
| Manufacturer | Terumo Corporation |
| Models | 13916501, 13988483, 13988481, 13916487, 13961167, 13961184, 13979995, 13916484, 13491294, 13961178, 13916493, 13950530 and 44 more |
| Date | Dec 12, 2024 |
| 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