FLOSEAL [Hemostatic Matrix] Indications

FLOSEAL is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

Important Risk Information

Do not use FLOSEAL in patients with known allergies to materials of bovine origin.

Do not use FLOSEAL in the closure of skin incisions because it may interfere with the healing of the skin edges.

FLOSEAL must not be injected into blood vessels, or allowed to enter blood vessels. Do not apply in the absence of active bleeding. Extensive intravascular clotting and even death may result.

FLOSEAL is made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

FLOSEAL is not intended as a substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for hemostasis.

Excess FLOSEAL (material not incorporated in the hemostatic clot) should always be removed by gentle irrigation from the site of application.

The maximum swell volume of approximately 20% is achieved within about 10 minutes.

FLOSEAL should not be used in conjunction with methylmethacrylate or other acrylic adhesives. Do not use FLOSEAL on bone surfaces where adhesives will be required to attach a prosthetic device.

RX only: For safe and proper use of this device, please refer to full device Instructions For Use.

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