International safety notice
A medical institution has notified us that the medical device was used in the "Blood purification device AcuFil Multi 55X-II" (trade name). During this time, we received a report that a "clamp opening/closing failure" occurred when the bubble clamp opened/closed. As a result of the investigation, the cause was that the wall thickness of the tube was large in some models, and the clamp was not sufficient to close the tube. We are conducting a voluntary recall as we have discovered that this is the case.
Japan / PMDA Recalls · JPN · Mar 3, 2023
Key facts
| Title | A medical institution has notified us that the medical device was used in the "Blood purification device AcuFil Multi 55X-II" (trade name). During this time, we received a report that a "clamp opening/closing failure" occurred when the bubble clamp opened/closed. As a result of the investigation, the cause was that the wall thickness of the tube was large in some models, and the clamp was not sufficient to close the tube. We are conducting a voluntary recall as we have discovered that this is the case. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Blood circuit for versatile blood processing Brand name: JMS blood purification circuit (for 55X series only) |
| Manufacturer | JMS Co., Ltd. |
| Models | 200512.64／200526.64／200613.65／200624.64／200709.64／200811.65／201111.64／, JCH-55X2-PE-S-1, 200414.64／200603.64, 211210.64／220526.64／220722.64／220917.65, JCH-55X2-CHDF-S-1 |
| Date | Mar 3, 2023 |
| 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