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 decided to carry out a voluntary recall of the affected products that were shipped.
Japan / PMDA Recalls · JPN · Dec 23, 2021
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 decided to carry out a voluntary recall of the affected products that were shipped. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Polydioxanone Suture Sales name: Monoplus |
| Manufacturer | B.Brown Ace Scrap Co., Ltd. |
| Models | 121354, M0024949 |
| Date | Dec 23, 2021 |
| 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