International safety notice
Regarding the BLU tracheostomy tube that we manufacture and sell, in a specific lot of this product from an overseas manufacturer, Due to a manufacturing issue, the pilot balloon used to inflate the tracheostomy cuff was removed from the inflation line. As it became clear that there was a possibility that the product might come off, we were informed that a voluntary recall would be conducted for the lot. Furthermore, upon receiving this notification, we will consider the quality, efficacy, safety, impact on patients, and compliance with laws and regulations of the product. We have decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Oct 3, 2024
Key facts
| Title | Regarding the BLU tracheostomy tube that we manufacture and sell, in a specific lot of this product from an overseas manufacturer, Due to a manufacturing issue, the pilot balloon used to inflate the tracheostomy cuff was removed from the inflation line. As it became clear that there was a possibility that the product might come off, we were informed that a voluntary recall would be conducted for the lot. Furthermore, upon receiving this notification, we will consider the quality, efficacy, safety, impact on patients, and compliance with laws and regulations of the product. We have decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Single-use tracheostomy tube Brand name: BLU tracheostomy tube |
| Manufacturer | Smith Medical Japan Co., Ltd. |
| Models | 4276631, 4303380, 4009810, 4191167, 4254571, 4238235, 4138224, 4054787, 4209002, 4270939, 4306004, 4197019 and 525 more |
| Date | Oct 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