International safety notice
The manufacturer, Intersurgical, has announced that the patient-side connector of this product has come loose from the tube, which is a problem that has been reported to overseas medical institutions. After receiving a report from the agency and conducting an investigation at the manufacturer, it was determined that the possibility of the same defect occurring in the relevant lot was ruled out. We have received a report that a recall will be implemented due to unforeseen circumstances. After checking our shipping records, we confirmed that the affected product had been shipped to the market, so we decided to carry out a voluntary recall. We have decided.
Japan / PMDA Recalls · JPN · Jun 12, 2023
Key facts
| Title | The manufacturer, Intersurgical, has announced that the patient-side connector of this product has come loose from the tube, which is a problem that has been reported to overseas medical institutions. After receiving a report from the agency and conducting an investigation at the manufacturer, it was determined that the possibility of the same defect occurring in the relevant lot was ruled out. We have received a report that a recall will be implemented due to unforeseen circumstances. After checking our shipping records, we confirmed that the affected product had been shipped to the market, so we decided to carry out a voluntary recall. We have decided. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Single Use Ventilator Breathing Circuit Brand name: Intersurgical single-use connector |
| Manufacturer | Japan Medical Next Co., Ltd. |
| Models | 3502000, 7220483 |
| Date | Jun 12, 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