International safety notice
Regarding this product, multiple medical institutions have confirmed that the sterilization packaging (secondary packaging) of some of the products in this lot is properly sealed. We have received a report that this is not being done. As the risk of similar incidents occurring cannot be denied, we have decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · May 22, 2023
Key facts
| Title | Regarding this product, multiple medical institutions have confirmed that the sterilization packaging (secondary packaging) of some of the products in this lot is properly sealed. We have received a report that this is not being done. As the risk of similar incidents occurring cannot be denied, we have decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Single-use subcutaneous conduction tunneler Sales name: Disposable tunneler |
| Manufacturer | B.Brown Ace Scrap Co., Ltd. |
| Models | 52806325, FV004R |
| Date | May 22, 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