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exsalt PT7 Contact Layer, 4" x 66"

Exciton Technologies Inc · Model PN-09-0130 · UDI-DI 07540127000529

FRO Prescription

510(k) clearances

3,166

Adverse events (64 deaths)

Recalls

385

Facilities

Description

The exsalt PT7 Contact Layer contains silver that inhibits bacterial growth in the dressing, as shown in-vitro for up to 7 days against Staphylococcus aureus, Enterococcus faecalis, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa, and Acinetobacter baumanii. The exsalt PT7 Contact Layer consists of three layers: Two non adherent polyethylene mesh wound contact layers and an absorbent core made of polyester; all three layers are silver coated. The concentration of silver on the exsalt PT7 Contact Layer is approximately 0.4 mg/cm2 (4.5% w/w). The exsalt PT7 Contact layer meets pyrogen limit specifications. The exsalt PT7 Contact Layer is indicated for use in partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, grafts, and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds.

Recalls

Date	Firm	Reason
2026-06-08	ConvaTec, Inc	Surgical dressing manufactured out of specification (greater thickness).
2026-04-27	Oculus 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
2026-01-16	Integra LifeSciences Corp. (NeuroSciences)	Potential packaging failures, which could lead to a breach in the sterile barrier.
2026-01-16	Integra LifeSciences Corp. (NeuroSciences)	Potential packaging failures, which could lead to a breach in the sterile barrier.
2026-01-16	Integra LifeSciences Corp. (NeuroSciences)	Potential packaging failures, which could lead to a breach in the sterile barrier.
2026-01-05	Medline Industries, LP	Medline 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
2026-01-05	Medline Industries, LP	Medline 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
2025-08-05	Integra LifeSciences Corp. (NeuroSciences)	Packaging failures were identified which could lead to a breach in the sterile barrier.
2025-08-05	Integra LifeSciences Corp. (NeuroSciences)	Packaging failures were identified which could lead to a breach in the sterile barrier.
2025-08-05	Integra 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.