Device Recall Secure, Coram

  • Model / Serial
    All lots are being recalled. Lot code consists of the five digit product code followed by a dash followed by a unique five character numeric or alphanumeric sequence. Affected product codes for this product: 66617, 66622, 66632, 66642, 69616, 69621, 69631, and 69641
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product distributed to medical facilities in the following US states: AL, AZ, CA, CO, CT, FL, IA, IL, KS, LA, MA, MD, MN, NC, OH, PA, PR, TN, TX, UT, and WA. Product was also distributed internationally to the following countries: Australia, Canada, Dominican Republic, Malaysia, Turkey, and United Kingdom
  • Product Description
    Dual Chamber Container fill with gravity/attached transfer sets, 250 mL / 1250 mL, 300 mL / 1700 mL, 500 mL / 2500 mL, 500 mL / 3500 mL
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    The Metrix Company, 4400 Chavenelle Rd, Dubuque IA 52002-2655
  • Manufacturer Parent Company (2017)
  • Source
    USFDA