International safety notice
The tracheostomy tube included in the percutaneous tracheostomy kit that we manufacture and sell is manufactured by an overseas manufacturer. Due to a manufacturing issue, the pilot bar used to inflate the tracheostomy cuff has been removed in certain lots of this product. We have conducted a voluntary recall of this lot because it has been determined that the rune may fall outside the inflation line. I received a message to that effect. In consideration of legal compliance, we have decided to voluntarily recall the affected products.
Japan / PMDA Recalls · JPN · Oct 2, 2024
Key facts
| Title | The tracheostomy tube included in the percutaneous tracheostomy kit that we manufacture and sell is manufactured by an overseas manufacturer. Due to a manufacturing issue, the pilot bar used to inflate the tracheostomy cuff has been removed in certain lots of this product. We have conducted a voluntary recall of this lot because it has been determined that the rune may fall outside the inflation line. I received a message to that effect. In consideration of legal compliance, we have decided to voluntarily recall the affected products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Upper airway tracheostomy kit Brand name: Percutaneous tracheostomy kit |
| Manufacturer | Smith Medical Japan Co., Ltd. |
| Models | 4224557, 4310419, 4270948, 4208994, 4281154, 4348840, 4310416, 4310412, 4238178, 4281202, 4234758, 4281033 and 33 more |
| Date | Oct 2, 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