Device Recall WARM AIR WARMING UNIT

  • Model / Serial
    Product # 82542; Catalog # 542; Lot #: 07279, 07280, 07424 & 08813.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States (AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI & WV), Canada, France, Germany, Ireland, Israel, New Zealand, Singapore, and The Netherlands.
  • Product Description
    FilteredFlo¿ Cardiac Blanket. || The device is used to distribute heated air around a patient (for patient warming).
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Cincinnati Sub-Zero Products Inc, 12011 Mosteller Rd, Cincinnati OH 45241-1528
  • Manufacturer Parent Company (2017)
  • Source
    USFDA