International safety notice
Medical institutions in Japan have reported cases where it is difficult to pass the guide wire through the luer connector of the catheter. An investigation into the manufacturer revealed that some products may contain Luer connectors that do not meet the specifications due to problems in the molding process. I did. Did.
Japan / PMDA Recalls · JPN · Feb 1, 2024
Key facts
| Title | Medical institutions in Japan have reported cases where it is difficult to pass the guide wire through the luer connector of the catheter. An investigation into the manufacturer revealed that some products may contain Luer connectors that do not meet the specifications due to problems in the molding process. I did. Did. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Pulmonary artery catheter Brand name: Wedge pressure catheter |
| Manufacturer | Gadelius Medical Co., Ltd. |
| Models | 1015489, CI-213, 1015490 |
| Date | Feb 1, 2024 |
| 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