International safety notice
This product is an instrument used for hemodynamic measurements, angiography and other tests/treatments, catheter tests, etc. The manufacturer has informed us that products manufactured using a specific individual packaging machine may have extremely fine particles in the individual packaging film due to manufacturing defects. We have received a report that the product will be recalled due to damage and it has been discovered that sterility may not be maintained. I did. Therefore, we have decided to voluntarily recall products with specific product numbers and serial numbers.
Japan / PMDA Recalls · JPN · Aug 31, 2021
Key facts
| Title | This product is an instrument used for hemodynamic measurements, angiography and other tests/treatments, catheter tests, etc. The manufacturer has informed us that products manufactured using a specific individual packaging machine may have extremely fine particles in the individual packaging film due to manufacturing defects. We have received a report that the product will be recalled due to damage and it has been discovered that sterility may not be maintained. I did. Therefore, we have decided to voluntarily recall products with specific product numbers and serial numbers. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Stopcock for general purpose blood flow path Sales name: Namic Manifold Stopcock and Deity |
| Manufacturer | Nipro Co., Ltd. |
| Models | 5659327, 0000007641, 70035003, 0000006313, 49-279, 70035002, 49-282, 0000012300, 70035008, 49-272, 49-277, 5656220 and 8 more |
| Date | Aug 31, 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