International safety notice
We have received information that the lot number displayed on the label is different between the outer box and inner bag. Upon investigation, a similar phenomenon was confirmed in a specific lot. We have decided to voluntarily recall the affected product lots.
Japan / PMDA Recalls · JPN · Feb 16, 2022
Key facts
| Title | We have received information that the lot number displayed on the label is different between the outer box and inner bag. Upon investigation, a similar phenomenon was confirmed in a specific lot. We have decided to voluntarily recall the affected product lots. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Balloon-expandable valvuloplasty catheter Brand name: NuMED valve dilation catheter |
| Manufacturer | Tritec Co., Ltd. |
| Models | TH-38688, PDC506, TH-38689, PDC507 |
| Date | Feb 16, 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