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Advazorb Sacral
BRIGHTWAKE LIMITED · Model CR4501 · UDI-DI 05060031482126
4
510(k) clearances
1,404
Adverse events (6 deaths)
9
Recalls
501
Facilities
Description
Absorbent foam sacral dressing with film backing, 17cm x 19cm. Advazorb Sacral is a soft, conforming, low adherent polyurethane foam wound dressing with pink polyurethane film backing and soft silicone contact layer that adheres only to normal healthy skin Advazorb Sacral has high fluid absorbency and retention characteristics. Advazorb Sacral also contributes to a pressure relieving protocol when used in conjunction with pressure relieving devices.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-18 | DeRoyal Industries Inc | Sterile wound dressing, lacks sterility assurance |
| 2025-02-19 | MEDLINE INDUSTRIES, LP - Northfield | There is a potential for the sterility of the device to be compromised. |
| 2024-10-01 | Advanced Medical Solutions Ltd. | Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier. |
| 2024-10-01 | Advanced Medical Solutions Ltd. | Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier. |
| 2024-10-01 | Advanced Medical Solutions Ltd. | Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier. |
| 2024-02-27 | ConvaTec, Inc | The product does not meet sterility assurance level. |
| 2024-01-23 | MEDLINE INDUSTRIES, LP - Northfield | Product failed sterility testing. |
| 2016-06-08 | Amd-Ritmed, Inc. | The lot of transparent dressing was found to be contaminated (not sterile) based on FDA sampling and analysis. |
| 2004-01-19 | DeRoyal Surgical Tray | Hydrophilic powder wound dressing, sterilized at a dosage which subsequently failed a sterility audit, was distributed. |
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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.