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Mepilex® Border Sacrum
Mölnlycke Health Care AB · Model 282455 · UDI-DI 07333350899844
4
510(k) clearances
1,397
Adverse events (6 deaths)
9
Recalls
501
Facilities
Description
Mepilex Border Sacrum, US 22 x 25 cm
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.