SURGICEL® Powder Absorbable Hemostat

The next generation of the #1 brand of absorbable adjunctive hemostats is built to stop continuous, broad-surface oozing fast—even on friable or raw tissues.570,571

Gets to the source of the bleed570,572

The unique structure of the powder penetrates the surface of the blood to get to the source of the bleeding. 570,572

Blood saturates the material, providing a surface for platelet adhesion and aggregation, and initiating cloat formation. 570,572

Adherent Hemostasis

After hemostasis has been achieved, the source will not rebleed even if SURGICEL® Powder is irrigated.571

SURGICEL® Powder efficiently and effectively controls continuous oozing on broad surfaces and fully absorbs within 7 to 14 days573,574

Proven bactericidal246,255,575

Bactericidal activity against the top five hospital-acquired pathogens (MRSA, MRSE, VRE, PRSP, E. coli) 246,255,575

Localized reduction in blood pH results in bactericidal activity against a broad range of gram-positive and gram-negative organisms, including antibiotic-resistant bacteria.246,255,575

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SURGICEL® Powder Absorbable Hemostat

PRODUCT CODE DESCRIPTION Device-Specific Actions QUANTITY PER BOX
3013SP SURGICEL Powder 3.0 grams 5 units
 

SURGICEL Powder Absorbable Hemostat Essential Product Information

INDICATIONS

SURGICEL® Powder (oxidized regenerated cellulose) is used adjunctively in surgical procedures to assist in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective.

CONTRAINDICATIONS

  • Do not inject or place SURGICEL Powder into an open blood vessel.
  • should not be used to control hemorrhage from large arteries.
  • When SURGICEL Powder is used to help achieve hemostasis in, around, or in proximity to foramina in bone, areas of bony confine, the spinal cord, or the optic nerve and chiasm, it must always be removed after hemostasis is achieved since it will swell and could exert unwanted pressure.
  • SURGICEL Powder should not be used for implantation in bone defects, such as fractures, since there is a possibility of interference with callus formation and a theoretical chance of cyst formation.

WARNINGS

  • Closing with SURGICEL Powder in a contaminated wound without drainage may lead to complications and should be avoided.
  • SURGICEL Powder should not be impregnated with anti-infective agents or with other materials such as buffering or hemostatic substances.
  • SURGICEL Powder is dry and there may be difficulties in precise delivery under certain circumstances. Unintentional device placement may result in powder scattering and device migration that may increase the risk of adhesion formation.
  • Although SURGICEL Powder is bactericidal against a wide range of pathogenic microorganisms, it is not intended as a substitute for systemically administered therapeutic or prophylactic antimicrobial agents to control or to prevent postoperative infections.
  • Do not attempt to trim the applicator tip.

PRECAUTIONS

  • SURGICEL Powder should not be used in conjunction with autologous blood salvage circuits, because its fragments may pass through the transfusion filters of blood-scavenging systems.
  • Use only as much SURGICEL Powder (oxidized regenerated cellulose) as is necessary and apply only where needed for hemostasis. Remove any excess before surgical closure in order to facilitate absorption and to minimize the possibility of foreign body reaction.
  • In urological procedures, minimal amounts of SURGICEL Powder should be used and care must be exercised to prevent plugging of the urethra, ureter, or a catheter by dislodged portions of the product.
  • Since absorption of SURGICEL Powder could be prevented in chemically cauterized areas, its use should not be preceded by application of silver nitrate or any other escharotic chemicals.
  • If SURGICEL Powder is used temporarily to line the cavity of open wounds, it should be removed by irrigation with sterile water or saline solution after bleeding has stopped.
  • Precautions should be taken in otorhinolaryngologic surgery to ensure that none of the material is aspirated by the patient (e.g., controlling hemorrhage after tonsillectomy and controlling epistaxis).
  • This applicator tip is not intended for laparoscopic or other endoscopic use.

ADVERSE EVENTS

  • Paralysis and nerve damage have been reported when other SURGICEL® products were used around, in, or in proximity to foramina in bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm.
  • Blindness has been reported in connection with surgical repair of a lacerated left frontal lobe when other SURGICEL® products were placed in the anterior cranial fossa (see WARNINGS and PRECAUTIONS).
  • Foreign body reactions have been reported with other products from the SURGICEL® Family of Absorbable Hemostats.
  • Burning has been reported when other SURGICEL® products were applied after nasal polyp removal. Headache, burning, stinging, and sneezing in epistaxis and other rhinological procedures, and stinging when SURGICEL® product was applied on surface wounds (varicose ulcerations, dermabrasions, and donor sites) have also been reported.

For more information and technical questions, call 1-800-795-0012.

Site References

  • *In an animal model
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