International safety notice
An internal investigation confirmed that the silicone coating process that should have been applied to the affected products was not applied to some lots. I did. We are implementing a voluntary recall because a product that differs from the original specifications was shipped.
Japan / PMDA Recalls · JPN · Apr 5, 2023
Key facts
| Title | An internal investigation confirmed that the silicone coating process that should have been applied to the affected products was not applied to some lots. I did. We are implementing a voluntary recall because a product that differs from the original specifications was shipped. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Sterile puncture needle for anesthesia Brand name: UNIEVER puncture needle |
| Manufacturer | Unisys Co., Ltd. |
| Models | 23B496, 23B531 |
| Date | Apr 5, 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