International safety notice
Complaint monitoring carried out by the overseas manufacturer Cordis revealed that the product's accessories "catheter" We have confirmed an increase in the frequency of complaints regarding the disconnection of the male connector of the "Extension Tube". As a result of the investigation, it was found that the products in which the male connector broke off were made from a common molding lot. We have decided to voluntarily recall products using these molded lots.
Japan / PMDA Recalls · JPN · Nov 8, 2022
Key facts
| Title | Complaint monitoring carried out by the overseas manufacturer Cordis revealed that the product's accessories "catheter" We have confirmed an increase in the frequency of complaints regarding the disconnection of the male connector of the "Extension Tube". As a result of the investigation, it was found that the products in which the male connector broke off were made from a common molding lot. We have decided to voluntarily recall products using these molded lots. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: central circulatory system angiography catheter Brand name: Cordis DX Catheter |
| Manufacturer | Cordis Japan LLC |
| Models | 18074058, 502-102D, 18060997 |
| Date | Nov 8, 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