FLOSEAL + RECOTHROM
Unmatched Speed. Reliable Hemostasis. FLOSEAL + RECOTHROM is the first & only active flowable hemostat to use recombinant DNA technology.
FLOSEAL remains the same effective hemostat you’ve trusted for 20+ years, innovated with the technology of RECOTHROM which allows for even faster product preparation.1
The Benefits of RECOTHROM
Manufacturing Process3
RECOTHROM Thrombin Topical (Recombinant) is manufactured in a laboratory using recombinant DNA technology. The DNA sequence for human thrombin is isolated and replicated in a lab.3
No human blood components3
Manufactured using recombinant DNA technology3
Structurally similar to human thrombin3
Same amino acid sequence as human thrombin with reduced risk of viral or disease transmission3
Eliminate reliance on human blood donations3
Uses innovative technology to source thrombin3
What's in the Box?3
Why the Change?
We understand that time in the OR is critical. FLOSEAL with RECOTHROM has the same, easy-to-use preparation steps but is now faster to prepare,2 enhancing the customer experience.
*FLOSEAL with RECOTHROM is faster to prepare than FLOSEAL with Human Thrombin. For 10 mL, FLOSEAL with RECOTHROM saved 78 seconds of preparation time. For 5 mL, FLOSEAL with RECOTHROM saved 41 seconds of preparation time.2
Learn why FLOSEAL with RECOTHROM is the most preferred flowable hemostat2
FLOSEAL with RECOTHROM vs. FLOSEAL with Human Thrombin
FLOSEAL with RECOTHROM has more than 1.5x faster prep time than FLOSEAL with Human Thrombin2
FLOSEAL with RECOTHROM vs. Surgiflo
FLOSEAL with RECOTHROM is easier and faster to prepare than Surgiflo2
Easy to Prepare2
The preparation steps for preparing FLOSEAL with RECOTHROM remain unchanged from our current FLOSEAL with human thrombin.3,4 This in-service video will guide you through the preparation steps for FLOSEAL with RECOTHROM. Watch the video to help plan for your live in-service training. Contact your Baxter Advanced Surgery Representative to schedule training.
Important Information
New Code
FLOSEAL with RECOTHROM
5 mL: ADS202105 (case of 6)
10 mL: ADS202110 (case of 6)
Please ensure the new code is updated in your Electronic Ordering Systems and Pharmacy Systems (i.e., PYXIS).
In-service Training
Upon completion of an in-service training at your facility by your Baxter Advanced Surgery Sales Representative, you will have access to order FLOSEAL with RECOTHROM.
Ordering Information
For ordering assistance please contact Baxter Center for Service: 888-229-0001 (prompt 3)
You can also order by visiting our Online Catalog.
FLOSEAL with RECOTHROM Indications and Important Risk Information
FLOSEAL Hemostatic Matrix Indication
FLOSEAL Matrix 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 inject intravascularly.
Do not inject or compress FLOSEAL Matrix into blood vessels.
Do not apply FLOSEAL Matrix in the absence of active blood flow, e.g., while the vessel is clamped or bypassed, as extensive intravascular clotting and even death may result.
Do not use FLOSEAL Matrix in patients with known allergies to materials of bovine origin.
Do not administer to patients with a history of hypersensitivity to RECOTHROM thrombin, any components of RECOTHROM, or hamster proteins. Hypersensitivity reactions, including anaphylaxis, may occur. RECOTHROM thrombin is produced in a genetically modified Chinese Hamster Ovary (CHO) cell line and may contain hamster or snake proteins.
Antibody formation to RECOTHROM occurred in <1% of patients. None of the antibodies detected neutralized native human thrombin.
Thrombin must be added to the Gelatin Matrix prior to use.
Do not use FLOSEAL Matrix in the closure of skin incisions because it may interfere with the healing of the skin edges.
FLOSEAL Matrix is not intended as a substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for hemostasis.
FLOSEAL Matrix should not be used for the primary treatment of coagulation disorders.
The safety and effectiveness for use in neurological and urological procedures has not been established through randomized clinical studies.
Excess FLOSEAL Matrix (material not incorporated in the hemostatic clot) should always be removed by gentle irrigation from the site of application.
The particles of FLOSEAL Matrix swell approximately 10-20% upon contact with blood or other fluids creating a tamponade effect. Maximum swell volume is achieved within about 10 minutes.
It is not known whether FLOSEAL Matrix can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. FLOSEAL Matrix should be administered to a pregnant woman only if clearly needed.
The safety and effectiveness of the combined use of FLOSEAL Matrix with antibiotic solutions or powders has not been established.
Do not use air to remove residual FLOSEAL Matrix from Applicator tip. The Applicator tips should not be cut, as tissue injury from sharp edges may result.
Do not use FLOSEAL Matrix on bone surfaces where adhesives, such as methylmethacrylate or other acrylic adhesives, will be required to attach a prosthetic device.
As with other hemostatic agents, do not apply FLOSEAL Matrix to sites where there is negative peripheral venous pressure (e.g. due to patient positioning), as material may be drawn into the vascular system potentially resulting in life-threatening thromboembolic events.
Rx Only. For safe and proper use of this device, refer to the full Instructions for Use.