International safety notice
Complaints about black-brown stains on products were reported overseas, and an investigation was conducted at the overseas manufacturer. It was discovered that the lubricant (mineral oil) used in the process may have adhered to the product. Based on this result, we place emphasis on the health hazards to patients, and we will We have decided to voluntarily recall the products (2 lots).
Japan / PMDA Recalls · JPN · Mar 31, 2023
Key facts
| Title | Complaints about black-brown stains on products were reported overseas, and an investigation was conducted at the overseas manufacturer. It was discovered that the lubricant (mineral oil) used in the process may have adhered to the product. Based on this result, we place emphasis on the health hazards to patients, and we will We have decided to voluntarily recall the products (2 lots). |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Antibacterial wound dressing/protection material Sales name: Aquacell Ag Foam |
| Manufacturer | Convatec Japan Co., Ltd. |
| Models | 10cmｘ10cm, 1C03858, 2C03689 |
| Date | Mar 31, 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