Device Recall ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin

  • Model / Serial
    PMA: P990004 Medical Device Listing Number: D100622  Product Code 2993  Lot/Batch Numbers:  239346 Exp Jan-13 239411 Exp Jun-13
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Russia, China, and the European Union.
  • Product Description
    ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville, NJ 08876 USA || Ref 2993 || SURGIFLO Hemostatic Matrix, mixed with sterile saline or thrombin solution, is indicated for surgical procedures (except ophthalmic) for hemostasis, when control of capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical. This is a topical absorbable hemostat consisting of a flowable gelatin matrix (paste) and a lyophilized Thrombin component. This kit also contains components necessary for preparing and applying the matrix during surgery.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Ethicon, Inc., US Highway 22 West, Somerville NJ 08876
  • Manufacturer Parent Company (2017)
  • Source
    USFDA