International safety notice
We have received three reports of product leaks in Japan and overseas. After receiving the returned products and conducting an analysis on two of them, we found that there was no communication between the lumens within the back form of the product. confirmed. An investigation by the manufacturer revealed that the incident occurred due to insufficient manufacturing procedures. We will carry out a voluntary recall of the lots in which there is a possibility.
Japan / PMDA Recalls · JPN · Aug 3, 2021
Key facts
| Title | We have received three reports of product leaks in Japan and overseas. After receiving the returned products and conducting an analysis on two of them, we found that there was no communication between the lumens within the back form of the product. confirmed. An investigation by the manufacturer revealed that the incident occurred due to insufficient manufacturing procedures. We will carry out a voluntary recall of the lots in which there is a possibility. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: fiber optic oximetry catheter Brand name: CV oximetry catheter Pediasat |
| Manufacturer | Edwards Lifesciences Co., Ltd. |
| Models | 63350873, 63045884, 62714762, 62728572, 62889102, 63080087, 63374025, 62706301, 63256056, 62544662, 63176482, XT358SJ and 6 more |
| Date | Aug 3, 2021 |
| 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