International safety notice
It has been discovered that some cannula products may have insufficient adhesive in their Tyvek packaging, resulting in poor sealing. As a result, we have decided to carry out a voluntary recall of products with specific lot numbers.
Japan / PMDA Recalls · JPN · Mar 21, 2024
Key facts
| Title | It has been discovered that some cannula products may have insufficient adhesive in their Tyvek packaging, resulting in poor sealing. As a result, we have decided to carry out a voluntary recall of products with specific lot numbers. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common names: (1) heart-lung bypass circuit system, (2) aortic cannula, (3) vena cava cannula. Sales name: (1) Balance custom pack (2) DLP cardioplegia fluid injection cannula, DLP aortic cannula (3) DLP heart-lung machine cannula, DLP vena cava cannula |
| Manufacturer | Japan Medtronic Co., Ltd. |
| Models | 2023041441, 2023040074, 2023041284, 12010, 2023040913, 2023040565, 2023040589, 67526, 67312, 2023040854, 77110, 30004 and 45 more |
| Date | Mar 21, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 Matching catalog numbers in FDA data
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