International safety notice
We have received a report of a problem where the ring part (bag part) of this product comes off from the connection adapter. Upon investigation, we found that if the welding process at the end of the ring is located outside the connection adapter, it may not be strong enough. It has been discovered that similar problems may occur. We have decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Nov 14, 2023
Key facts
| Title | We have received a report of a problem where the ring part (bag part) of this product comes off from the connection adapter. Upon investigation, we found that if the welding process at the end of the ring is located outside the connection adapter, it may not be strong enough. It has been discovered that similar problems may occur. We have decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Single-use endoscopic non-active treatment device for natural opening (38819001) Sales name: End Carry |
| Manufacturer | Hakko Co., Ltd. |
| Models | 230715, 230303, 220209, 29115025, 220428, 221006, 220702, 220906, 220714, 230429, 29112010, 220311 and 3 more |
| Date | Nov 14, 2023 |
| 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