International safety notice
Regarding the raw materials for the PTFE coating sold under the trade name (1), the PTFE coating sold under the trade name (2), and the plastic jacket. We have made a change based on a minor change notification, but the change requires partial change approval. It turned out that. Therefore, we will collect it voluntarily.
Japan / PMDA Recalls · JPN · Jun 14, 2023
Key facts
| Title | Regarding the raw materials for the PTFE coating sold under the trade name (1), the PTFE coating sold under the trade name (2), and the plastic jacket. We have made a change based on a minor change notification, but the change requires partial change approval. It turned out that. Therefore, we will collect it voluntarily. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Cardiac/Central Circulatory System Catheter Guidewire Sales name: (1) Extension wire (2) HB-IVR guide wire II |
| Manufacturer | Filmec Co., Ltd. |
| Models | 220527R031, 210506R021, 200602R041, 220308R011, 221022R021, 220924R021, 230313R101, 211216R041, 220706R021, 210225R051, 201026R021, 220531R021 and 169 more |
| Date | Jun 14, 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