International safety notice
Regarding the PORTEX/tracheostomy tubes that we manufacture and sell, we receive a specific lot of this product from an overseas manufacturer. the neck flange completely or partially detaches from the tracheostomy tube during use of the product due to a manufacturing defect. As it became clear that this was a possibility, we were informed that a voluntary recall of the lot in question would be conducted. Upon receiving this notification, the company will voluntarily review the product in consideration of product quality, efficacy, safety, impact on patients, and compliance with laws and regulations. I decided to make a collection.
Japan / PMDA Recalls · JPN · Apr 23, 2024
Key facts
| Title | Regarding the PORTEX/tracheostomy tubes that we manufacture and sell, we receive a specific lot of this product from an overseas manufacturer. the neck flange completely or partially detaches from the tracheostomy tube during use of the product due to a manufacturing defect. As it became clear that this was a possibility, we were informed that a voluntary recall of the lot in question would be conducted. Upon receiving this notification, the company will voluntarily review the product in consideration of product quality, efficacy, safety, impact on patients, and compliance with laws and regulations. I decided to make a collection. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Single-use tracheostomy tube Brand name: PORTEX/tracheostomy tube |
| Manufacturer | Smith Medical Japan Co., Ltd. |
| Models | 4187262, 4007560, 4050310, 4209858, 3897840, 3867128, 3907963, 4172983, 4068699, 3913219, 4206469, 4018228 and 2 more |
| Date | Apr 23, 2024 |
| 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