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Silflex
BRIGHTWAKE LIMITED · Model CR3925 · UDI-DI 05060031473025
10
510(k) clearances
15,775
Adverse events (7 deaths)
19
Recalls
511
Facilities
Description
Soft silicone wound contact layer 20 cm X 30 cm. A wound contact layer made from polyester mesh and coated with Silfix soft silicone. Silflex is designed to gently adhere to the skin surrounding a wound and not to the wound bed. This is an atraumatic dressing designed to minimise the pain and trauma associated with dressing change. The dressing’s large perforations allow for the passage of exudate and irrigation of wound.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-29 | ConvaTec, Inc | Wound dressing may have foreign matter on the product. |
| 2025-02-19 | MEDLINE INDUSTRIES, LP - Northfield | There is a potential for the sterility of the device to be compromised. |
| 2022-01-28 | Sam Medical Products | Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the dressing cannot be centered ov |
| 2021-08-20 | ConvaTec, Inc | Primary packaging labeling may be incorrect. |
| 2021-08-09 | ConvaTec, Inc | There is a potential for open seals which can compromise sterility. |
| 2018-08-01 | COVIDIEN LLC | Potential for product sterility breach due to a compromised or pinched seal defect |
| 2018-08-01 | COVIDIEN LLC | Potential for product sterility breach due to a compromised or pinched seal defect |
| 2018-08-01 | COVIDIEN LLC | Potential for product sterility breach due to a compromised or pinched seal defect |
| 2018-08-01 | COVIDIEN LLC | Potential for product sterility breach due to a compromised or pinched seal defect |
| 2018-08-01 | COVIDIEN LLC | Potential for product sterility breach due to a compromised or pinched seal defect |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.