International safety notice
Subcutaneous leakage was suspected during flushing with physiological saline, so when a contrast agent was injected under fluoroscopy, fluid leaked from the port. We received a report from a medical institution that there was a leak. As it has become clear that a product that does not meet the performance requirements may have been shipped, we have decided to recall the product. I did.
Japan / PMDA Recalls · JPN · Dec 27, 2022
Key facts
| Title | Subcutaneous leakage was suspected during flushing with physiological saline, so when a contrast agent was injected under fluoroscopy, fluid leaked from the port. We received a report from a medical institution that there was a leak. As it has become clear that a product that does not meet the performance requirements may have been shipped, we have decided to recall the product. I did. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Heparinized long-term use implantable port Sales name: East Report System |
| Manufacturer | Toray Industries, Inc. |
| Models | ２２０９２７, ＲＳＶ６０４０Ｆ１Ｍ, ２２０６２８, ２２０８３１, ＲＳＶ６０４０Ｆ３Ｍ, ２２０９２９, ２２０６３０, ２２０８２５, ２２１１２３, ＲＳＶ５０４０Ｍ２Ｍ, ＲＳＶ６０４０Ｍ２Ｍ, ２２１０２５ |
| Date | Dec 27, 2022 |
| 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