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ASSIST Silver Absorbent

MILLIKEN HEALTHCARE PDTS, LLC · Model 18"x24" · UDI-DI 00015961664147

FRO Prescription
1
510(k) clearances
3,166
Adverse events (64 deaths)
82
Recalls
385
Facilities

Description

ASSIST Silver Absorbent is a sterile, single use multi-layer low-adherent absorbent wound dressing. ASSIST Silver Absorbent is indicated for management of acute and chronic wounds: partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, lymphedema, dermatological wounds, and stage I-IV vascular ulcers, pressure ulcers, venous ulcers, and diabetic ulcers. ASSIST Silver Absorbent dressings provide an antimicrobial barrier and reduces microbial penetration through the dressing. The dressing is contraindicated for patients with a known silver sensitivity. The dressing has a low-adherent veil wound contact layer, a polyester/ nylon wound contact layer coated with an ion-exchange silver, two layers of absorptive non-woven, and a grey occlusive outer layer. The film outer layer (side placed away from the wound) is grey and embossed. The embossing is a circle logo with "ASSIST Silver" printed inside. The logo has "This side away from wound," embossed above and below.

Recalls

DateFirmReason
2026-06-08ConvaTec, IncSurgical dressing manufactured out of specification (greater thickness).
2026-04-27Oculus Technologies of Mexico, S.A. de C.V.The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material incompatibility between the produc
2026-01-16Integra LifeSciences Corp. (NeuroSciences)Potential packaging failures, which could lead to a breach in the sterile barrier.
2026-01-16Integra LifeSciences Corp. (NeuroSciences)Potential packaging failures, which could lead to a breach in the sterile barrier.
2026-01-16Integra LifeSciences Corp. (NeuroSciences)Potential packaging failures, which could lead to a breach in the sterile barrier.
2026-01-05Medline Industries, LPMedline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for
2026-01-05Medline Industries, LPMedline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for
2025-08-05Integra LifeSciences Corp. (NeuroSciences)Packaging failures were identified which could lead to a breach in the sterile barrier.
2025-08-05Integra LifeSciences Corp. (NeuroSciences)Packaging failures were identified which could lead to a breach in the sterile barrier.
2025-08-05Integra LifeSciences Corp. (NeuroSciences)Packaging failures were identified which could lead to a breach in the sterile barrier.

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Data 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.