Device Recall STAT 2 I.V. Gravity Flow NeedleFree Controller Primary Administration Sets and Extension Sets

  • Model / Serial
    Catalog Number, Manufacturing Date range, Lot Code range: (1) S2-12 N,4/27/12 - 4/12/17, 120427X - 201704124; (2) S2V-20 N, 4/27/12 - 11/7/17, 120427X - 201611074; and (3) S2V-60 N, 4/27/12 - 2/13/17, 120427X - 201702134
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, Washington, DC, Puerto Rico, and countries of: Lebanon, Panama, Saudi Arabia, Germany, India, and Canada.
  • Product Description
    STAT 2¿ I.V. Gravity Flow Needle-Free Controller Primary Administration Sets and Extension Sets (Catalog Numbers: (1) S2-12 N, STAT 2¿ Extension Set Gravity Flow Controller (Needle-Free), 12 length, (2) S2V-20 N, STAT 2¿ Primary Administration Set Gravity Flow Controller (Needle-Free), 20 Drops/ml, 84 length, and (3) S2V-60 N, STAT 2¿ Primary Administration Set Gravity Flow Controller (Needle-Free), 60 Drops/ml, 84 length) || The STAT 2¿ Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body. The STAT 2¿ Secondary and Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. This is a disposable device with a sterile, nonpyrogenic fluid path.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    ConMed Corporation, 525 French Rd, Utica NY 13502-5945
  • Manufacturer Parent Company (2017)
  • Source
    USFDA