International safety notice
There was a deviation from the storage temperature conditions stated in the precautions, etc. information at a specific distributor's outsourced warehouse. Since this has been confirmed, we are conducting a voluntary recall. Products whose storage temperature deviates may no longer meet the specified shelf life (24 months).
Japan / PMDA Recalls · JPN · Oct 5, 2023
Key facts
| Title | There was a deviation from the storage temperature conditions stated in the precautions, etc. information at a specific distributor's outsourced warehouse. Since this has been confirmed, we are conducting a voluntary recall. Products whose storage temperature deviates may no longer meet the specified shelf life (24 months). |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Coronary stent Brand name: Oscillo Mission Sirolimus-eluting Coronary Stent System |
| Manufacturer | Biotronic Japan Co., Ltd. |
| Models | 11226367, 09227479, 09226075, 09220276, 08222826, 08223699, 09227247, 12220859, 09220951, 11222981, 01233491, 08225804 and 257 more |
| Date | Oct 5, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 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