International safety notice
We have received multiple reports of the dilator being scraped off when it was set in the sheath. As a result, the dilator tube came into contact with the cross section of the braided wire exposed at the curved outer side hole of the sheath tube. Since we have discovered that the product has been scratched, we will voluntarily recall products that may cause similar problems.
Japan / PMDA Recalls · JPN · Feb 9, 2023
Key facts
| Title | We have received multiple reports of the dilator being scraped off when it was set in the sheath. As a result, the dilator tube came into contact with the cross section of the braided wire exposed at the curved outer side hole of the sheath tube. Since we have discovered that the product has been scratched, we will voluntarily recall products that may cause similar problems. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Cardiac Catheter Introducer Kit Sales name: Medikit Braided Sheath |
| Manufacturer | Togo Medikit Co., Ltd. |
| Models | 22L0232, BD0016, 22J1424, 22F10AL, 22F10AP, 22K2512, 22F03CN, 22K1832, 22L1616, 22F03CM, 22L0931, BS80A63EK-F1 and 70 more |
| Date | Feb 9, 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