International safety notice
In the trachea tube intrudusa that we manufacture and sell, we will contact you from the overseas manufacturer of the following two points. In response to this, we have decided to voluntarily recall the affected products in consideration of product quality, efficacy, safety, impact on patients, and compliance with laws and regulations. Thank you. (1) When disinfecting this product, liquid may enter between the end caps and tubes at the rear end of the product. may contaminate the product or allow liquid to remain inside the product. (2) Poclioxide solution (200 ppm) and 4 % acetic acid, which are the recommended disinfectant in the package, are insufficient as a disinfectant of this product. It may be.
Japan / PMDA Recalls · JPN · Jan 21, 2025
Key facts
| Title | In the trachea tube intrudusa that we manufacture and sell, we will contact you from the overseas manufacturer of the following two points. In response to this, we have decided to voluntarily recall the affected products in consideration of product quality, efficacy, safety, impact on patients, and compliance with laws and regulations. Thank you. (1) When disinfecting this product, liquid may enter between the end caps and tubes at the rear end of the product. may contaminate the product or allow liquid to remain inside the product. (2) Poclioxide solution (200 ppm) and 4 % acetic acid, which are the recommended disinfectant in the package, are insufficient as a disinfectant of this product. It may be. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Reusable tracheal introducer tube Brand name: Endotracheal tube introducer |
| Manufacturer | Smith Medical Japan Co., Ltd. |
| Models | 0003606, 0003636, 0003369, 0003615, 0003512, 0003401, 0003509, 0003415, 0003407, 0003524, 0003643, 0003610 and 41 more |
| Date | Jan 21, 2025 |
| 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