International safety notice
An internal investigation revealed that the actual status of the manufacturing facility responsible for the "main assembly" of the product differs from the description in the certification application documents. It turns out that.
Japan / PMDA Recalls · JPN · Jul 25, 2022
Key facts
| Title | An internal investigation revealed that the actual status of the manufacturing facility responsible for the "main assembly" of the product differs from the description in the certification application documents. It turns out that. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Eustachian tube catheter Brand name: Tympanic membrane tube |
| Manufacturer | Nagashima Medical Instruments Co., Ltd. |
| Models | V07HG |
| Date | Jul 25, 2022 |
| 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