Device Recall Secure, Vygon, Cormix, Invacare, and 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: 58781, 58785, 62005, 62010, 62015, 62025, 62030, 62035, 64005, 64010, 64015, 64025, 64030, 64035, 64781, 65005, 65010, 65015, 65025, 65030, 65035, 66005, 66010, 66015, 66020, 66025, 66030, 66035, 66305, 66310, 66315, 66325, 66330, 66335, 66705, 66710, 66715, 66725, 66730, 66735, 66910, 66915, 66925, 66930, 66935, 67005, 67010, 67015, 67025, 67030, 67035, 69005, 69010, 69015, 69025, 69030, 69035
  • 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
    Container fill and transfer sets, 250 mL, 500 mL, 1000 mL, 2000 mL, 3000 mL, or 4000 mL.
  • Manufacturer
  • 1 Event

Manufacturer

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