International safety notice
Regarding this product, the manufacturer, B.Brown S.A. Spain, has confirmed that sterile packaging is appropriate for some lots. We have received reports that the product may contain unsealed products. We have confirmed that the item has been shipped. Therefore, we have decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · May 9, 2023
Key facts
| Title | Regarding this product, the manufacturer, B.Brown S.A. Spain, has confirmed that sterile packaging is appropriate for some lots. We have received reports that the product may contain unsealed products. We have confirmed that the item has been shipped. Therefore, we have decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Polyglyconate Suture Brand name: Monosyn |
| Manufacturer | B.Brown Ace Scrap Co., Ltd. |
| Models | 121314, M0022939 |
| Date | May 9, 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