International safety notice
The outer diameter of the tip of this product is 25G (0.5mm), but some products with an outer diameter of 23G (0.6mm) are mixed in from the importing manufacturer. I received a message that it is. We have determined that such measures are necessary and have decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Oct 8, 2021
Key facts
| Title | The outer diameter of the tip of this product is 25G (0.5mm), but some products with an outer diameter of 23G (0.6mm) are mixed in from the importing manufacturer. I received a message that it is. We have determined that such measures are necessary and have decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Fiber Optic Surgical Illuminator Sales name: Dispo Total View Fiber Probe with Shield 25G (0.5mm) |
| Manufacturer | RL Medical Co., Ltd. |
| Models | 2401036, AU-3269SBS05S |
| Date | Oct 8, 2021 |
| 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