Device Recall GK213, AME Standard Kit

  • Model / Serial
    Lot #: 1239287
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    U.S .Nationwide Distribution in the states of GA, AL, LA, TX, MN, AK, CA, ID, OR, UT, WY, NM, and AZ. Foreign distirbution to the following; Austria, Belgium, Denmarl, Canada, Japan, France, Germany, Ireland, Italy, Greece, Netherlands, Russia, Spain, Switzerland, Turkey, Great Britain
  • Product Description
    STD KIT GK213, AME Standard Kit 15 || Product Usage: || The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Applied Medical Resources Corp, 22872 Avenida Empresa, Rancho Santa Margarita CA 92688-2650
  • Manufacturer Parent Company (2017)
  • Source
    USFDA