International safety notice
When using the AF-SGW circuit at a medical institution, the vendor advised that the circuit connector was incorrectly installed and could not be connected to the drainage bag. There was a report that. As a result of the investigation, it was discovered that the connector in the relevant lot 412235 was incorrectly installed. We have also decided to recall lot 412441, which cannot be ruled out as having a mislabeling error.
Japan / PMDA Recalls · JPN · Jun 24, 2024
Key facts
| Title | When using the AF-SGW circuit at a medical institution, the vendor advised that the circuit connector was incorrectly installed and could not be connected to the drainage bag. There was a report that. As a result of the investigation, it was discovered that the connector in the relevant lot 412235 was incorrectly installed. We have also decided to recall lot 412441, which cannot be ruled out as having a mislabeling error. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Blood circuit for versatile blood processing Brand name: Multipurpose blood purification circuit |
| Manufacturer | Naniwa Rubber Industry Co., Ltd. |
| Models | 412441, 412235, 132set |
| Date | Jun 24, 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