International safety notice
Each side of the individual packaging materials for this product is completely sealed by pressure bonding, but in-house verification tests have shown that certain packaging materials There is a possibility that a very small sealing defect (a gap leading from the inside of the packaging material to the outside) may exist in the lot of the packaging material. I understand. There is a risk of it happening. As a result of the investigation, it was found that three production lots of the sterilization bags had sealing defects, so this lot Overseas manufacturers have begun voluntary recall measures for products using sterilized bags. We have decided to launch similar voluntary recall measures.
Japan / PMDA Recalls · JPN · Jan 29, 2024
Key facts
| Title | Each side of the individual packaging materials for this product is completely sealed by pressure bonding, but in-house verification tests have shown that certain packaging materials There is a possibility that a very small sealing defect (a gap leading from the inside of the packaging material to the outside) may exist in the lot of the packaging material. I understand. There is a risk of it happening. As a result of the investigation, it was found that three production lots of the sterilization bags had sealing defects, so this lot Overseas manufacturers have begun voluntary recall measures for products using sterilized bags. We have decided to launch similar voluntary recall measures. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Single use centrifugal pump Brand name: ROTAFLOW centrifugal pump |
| Manufacturer | Getinge Group Japan Co., Ltd. |
| Models | 701005308, 3000282220, 3000284766, 701032035 |
| Date | Jan 29, 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