Device Recall IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump

  • Modèle / numéro de série
    OneTouch(R) Ping(TM) Glucose Management Systems - Part Numbers 101420-00, 101421-00, 101422-00, 101424-00, 101425-00, 100430-00, 100431-00, 100432-00, 100434-00, 100435-00, 101420-98, 101421-98, 101422-98, 101424-98, and 101425-98;   Animas(R) 2020 Insulin Infusion Pumps - Part numbers 101370-00, 101371-00, 101372-00, 101374-00, 101375-00, 100380-00, 100381-00, 100382-00, 100384-00, and 100385-00;   Animas(R) IR 1250 (1200 Plus) Insulin Infusion Pumps -- Part numbers 100250-00, 100251-00, and 100252-00; and   Animas(R) IR 1200 Insulin Infusion Pumps - Part numbers 100200-00, 100201-00, and 100202-00. Serial numbers -- will be provided.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including 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, RI, SC, SD, TN, TX, UT, V, VT, WA, WI, WV, WY and Washington, DC and countries of: Austria, Australia, Canada, Czech Republic, France, Finland, Germany, Hungary, Israel, Italy, Mexico, New Zealand, Puerto Rico, Spain, and United Kingdom.
  • Description du dispositif
    IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. || The device is intended to deliver insulin therapy.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Animas Corporation, 200 Lawrence Dr, West Chester PA 19380-3428
  • Source
    USFDA