International safety notice
We have received reports that the Maximum Expansion Pressure (RBP) on the compliance chart on the label affixed to the product box is incorrectly stated. I did. This is Teru. There is a possibility that the expansion pressure and expansion diameter that can be achieved may not be given, and products that may have the incorrect description are shipped to the market. We have decided to voluntarily recall the product of the relevant lot because it was confirmed that the product was contaminated.
Japan / PMDA Recalls · JPN · Oct 7, 2022
Key facts
| Title | We have received reports that the Maximum Expansion Pressure (RBP) on the compliance chart on the label affixed to the product box is incorrectly stated. I did. This is Teru. There is a possibility that the expansion pressure and expansion diameter that can be achieved may not be given, and products that may have the incorrect description are shipped to the market. We have decided to voluntarily recall the product of the relevant lot because it was confirmed that the product was contaminated. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Balloon-expandable angioplasty catheter Sales name: Quad Pro |
| Manufacturer | USCI Japan Co., Ltd. |
| Models | TRN21100001, TRN21120007, TRN22070017, TRN22020001, TRN21120003, TRN21120001, TRN21090001, TRN21100004, TRN21070001, TRN22070015, TRN22040002, TRN22040003 and 33 more |
| Date | Oct 7, 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