International safety notice
The manufacturer, Intersurgical, has notified overseas medical institutions of a problem in which the prongs and oxygen tube of the product came off. As a result of the report, we conducted an investigation and found that the possibility of this event occurring in some lots could not be denied. We have received a report that a recall will be carried out. 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 · Dec 14, 2022
Key facts
| Title | The manufacturer, Intersurgical, has notified overseas medical institutions of a problem in which the prongs and oxygen tube of the product came off. As a result of the report, we conducted an investigation and found that the possibility of this event occurring in some lots could not be denied. We have received a report that a recall will be carried out. 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: Oxygen administration kit Brand name: Intersurgical oxygen administration kit |
| Manufacturer | Japan Medical Next Co., Ltd. |
| Models | 32204165, 32105886, 32203136, 1164000 |
| Date | Dec 14, 2022 |
| 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