International safety notice
Regarding some lots of "Jagtome RX" (hereinafter referred to as "this product"), the sterile packaging was damaged at the overseas manufacturer. A certain product was detected and it was confirmed that the sterility of the product may not be guaranteed (hereinafter referred to as "this event"). say).
Japan / PMDA Recalls · JPN · Dec 17, 2021
Key facts
| Title | Regarding some lots of "Jagtome RX" (hereinafter referred to as "this product"), the sterile packaging was damaged at the overseas manufacturer. A certain product was detected and it was confirmed that the sterility of the product may not be guaranteed (hereinafter referred to as "this event"). say). |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Endoscopic active instrument for single-use radiofrequency procedures Sales name: Jagtome RX |
| Manufacturer | Boston Scientific Japan Co., Ltd. |
| Models | M00573000, 27737251, 27535120, M00573050, M00573070, 27690967, 27836207, 27970819, 27730949 |
| Date | Dec 17, 2021 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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