International safety notice
Due to insufficient welding of the obturator tube and sheath lock, the obturator was replaced by an overseas manufacturer. The fixed position of the obturator tube may shift or a gap may occur between the obturator tube and sheath lock. As a result, we were informed that we would be conducting a voluntary recall of the products from that lot. 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 · Aug 7, 2023
Key facts
| Title | Due to insufficient welding of the obturator tube and sheath lock, the obturator was replaced by an overseas manufacturer. The fixed position of the obturator tube may shift or a gap may occur between the obturator tube and sheath lock. As a result, we were informed that we would be conducting a voluntary recall of the products from that lot. 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: Endoscopic obturator Sales name: UL Visual Obturator |
| Manufacturer | Teleflex Medical Japan Co., Ltd. |
| Date | Aug 7, 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