International safety notice
Based on the results of an investigation at an overseas manufacturer, some lots are bundled with introducers with different tip processing. It turns out it's possible. Therefore, we have decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Jul 16, 2024
Key facts
| Title | Based on the results of an investigation at an overseas manufacturer, some lots are bundled with introducers with different tip processing. It turns out it's possible. Therefore, we have decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Cardiac/Central Circulatory System Catheter Guidewire Sales name: Synchro 2 Guide Wire |
| Manufacturer | Japan Striker Co., Ltd. |
| Models | 0000148427, 0000144318, 0000121919, 0000143125, 00000859, 0000145692, 0000141789, 0000123069, 0000077610, 0000124931, SSFT215STR, 0000085365 and 182 more |
| Date | Jul 16, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 1–9 Matching catalog numbers in FDA data
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