International safety notice
Conventionally, the plunger gasket (black rubber on the piston) was made of latex-free synthetic natural rubber (isoprene). Rubber: IR) was used, but on September 10, 2021, due to a notification from the importer, natural rubber was used as the material for the products in this lot. It was found that the ingredients were included. We are concerned about this and will be collecting it.
Japan / PMDA Recalls · JPN · Sep 30, 2021
Key facts
| Title | Conventionally, the plunger gasket (black rubber on the piston) was made of latex-free synthetic natural rubber (isoprene). Rubber: IR) was used, but on September 10, 2021, due to a notification from the importer, natural rubber was used as the material for the products in this lot. It was found that the ingredients were included. We are concerned about this and will be collecting it. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Manual biological irrigator Brand name: Nasarin |
| Manufacturer | Entry Japan Co., Ltd. |
| Models | 16765 |
| Date | Sep 30, 2021 |
| 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