International safety notice
When opening the product box of the target product (1), the medical department received a report that the product (2) with different sterilized packaging and product body was mixed in. machine Received from Seki. We will voluntarily recall any lots for which we cannot deny the possibility that the product may be contaminated.
Japan / PMDA Recalls · JPN · Aug 7, 2023
Key facts
| Title | When opening the product box of the target product (1), the medical department received a report that the product (2) with different sterilized packaging and product body was mixed in. machine Received from Seki. We will voluntarily recall any lots for which we cannot deny the possibility that the product may be contaminated. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Cardiac/Central Circulatory System Catheter Guidewire Brand name: FMD Guidewire |
| Manufacturer | FMD Co., Ltd. |
| Models | D17723F05, B15823F05, B15623F05, D15723F05, D17F23F05, B15723F05, B15523F05, B13G23F05, 300cm, B13F23F05, H749N0214S0104, D17E23F05 and 1 more |
| Date | Aug 7, 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