Device Recall PenAdapt"(PenAdapt is a TM of Buffalo Filter)

  • Model / Serial
    Part Number 0702-045-027
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV,and WY, and the countries of Austria, Canada, Sweden, England, UAE, Netherlands, Spain, and Hong Kong.
  • Product Description
    Stryker PenAdapt"; Rx Only, Sterile. || This device is an accessory to an electrosurgical unit (ESU). The PenAdapt is used to remove smoke, particles, and body and casual fluids from the point of surgical activity during surgical procedures that use ESU for cutting and cauterizing.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Manufacturer Parent Company (2017)
  • Source
    USFDA