International safety notice
An overseas manufacturer has announced that the 15mm connector connected to this product may come off during use. As a result of verification, we have been informed that a voluntary recall of the products in question will be carried out. For this reason, we have implemented a voluntary recall as we cannot deny the occurrence of similar defects in Japan as well. To do.
Japan / PMDA Recalls · JPN · Jun 19, 2023
Key facts
| Title | An overseas manufacturer has announced that the 15mm connector connected to this product may come off during use. As a result of verification, we have been informed that a voluntary recall of the products in question will be carried out. For this reason, we have implemented a voluntary recall as we cannot deny the occurrence of similar defects in Japan as well. To do. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: non-call type ventilation tracheal tube Brand name: RUSCH tracheal tube |
| Manufacturer | Teleflex Medical Japan Co., Ltd. |
| Models | KME20L1814, KME22B2646, 19LT51, KME22B2592, 20GT11, KME21G2548, KME21K1745, 19ET57, 19ET34, KME22C0009, KME21K1952, KME21G0831 and 280 more |
| Date | Jun 19, 2023 |
| 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