International safety notice
After investigating customer complaints received by overseas manufacturers from markets around the world, we found that It was discovered that the Beck cover could become punctured, compromising sterility. During transportation, the product becomes unsecured and moves within the packaging container, causing the protruding part of the product to come into contact with the Tyvek cover and create a hole. It has been confirmed that It has been decided.
Japan / PMDA Recalls · JPN · Aug 17, 2022
Key facts
| Title | After investigating customer complaints received by overseas manufacturers from markets around the world, we found that It was discovered that the Beck cover could become punctured, compromising sterility. During transportation, the product becomes unsecured and moves within the packaging container, causing the protruding part of the product to come into contact with the Tyvek cover and create a hole. It has been confirmed that It has been decided. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Heparinized heart-lung bypass circuit system Brand name: Auxiliary circulation system HLS Set Advanced |
| Manufacturer | Getinge Group Japan Co., Ltd. |
| Models | 3000223282, 3000217596, 3000212854, 701069073, 3000190533, 3000195593, 3000227590, 3000225894, 3000216173, 3000193371 |
| Date | Aug 17, 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