Device Recall Clear Cardioplegia Delivery Sets

  • Model / Serial
    Lot Numbers: MN08, MNI5, MM11, MM18, MM25.  Manufacturing dates October 1I, 2010 through Novemberl5, 20 I 0.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.
  • Product Description
    Terumo Cardioplegia Delivery Set- || Item Number: 16130 || Product Usage: || The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Terumo Cardiovascular Systems Corp, 28 Howe St, Ashland MA 01721-1305
  • Manufacturer Parent Company (2017)
  • Source
    USFDA