Device Recall FloSeal Endoscopic Applicator

  • Model / Serial
    Product Code: 1500181; Lot Numbers: 05H035, 06N005, 06N017, 07A043, 07B044, 07E025, 07F010, 07G031, 07H016, 07J029, 07K034, 07N007, 088048, 08C020, 08D017, 08D053, and 08E041
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide and worldwide to Puerto Rico, Colombia, Hong Kong, New Zealand, Australia, Austria, Belgium, Czech Republic, Denmark, Finland, France, Greece, Germany, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
  • Product Description
    FloSeal Endoscopic Applicator , Product Code 1500181. The product is indicated in surgical procedures (other than in neurosurgical, opthalmic, and urological) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Baxter Bioscience, 1 Baxter Way, Westlake Village CA 91362-3811
  • Manufacturer Parent Company (2017)
  • Source
    USFDA