International safety notice
Regarding the disposable silicone-reinforced tracheostomy tubes that we manufacture, we have received orders from overseas manufacturers. Due to a manufacturing defect in a particular lot of this product, it was discovered that the flange may be damaged. We have been informed that a voluntary recall will be conducted regarding this lot. Considering safety, impact on patients, and compliance with laws and regulations, we have decided to voluntarily recall the affected products.
Japan / PMDA Recalls · JPN · Jul 3, 2024
Key facts
| Title | Regarding the disposable silicone-reinforced tracheostomy tubes that we manufacture, we have received orders from overseas manufacturers. Due to a manufacturing defect in a particular lot of this product, it was discovered that the flange may be damaged. We have been informed that a voluntary recall will be conducted regarding this lot. Considering safety, impact on patients, and compliance with laws and regulations, we have decided to voluntarily recall the affected products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Reinforced tracheostomy tube for ventilation Brand name: Disposable silicone reinforced tracheostomy tube |
| Manufacturer | Smith Medical Japan Co., Ltd. |
| Models | 3884247, 4276484, 4163824, 4218689, 3949024, 4335072, 4335091, 4254275, 4168139, 3991205, 4128033, 4196301 and 1018 more |
| Date | Jul 3, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 10–99 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