Device Recall MiniPrime Cardioplegia Set with Conducer

  • Model / Serial
    Lot Numbers: MN08 Manufacturing Date November 8, 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 Custom Cardioplegia Delivery Sets || Catalog Code: 204880 || Product Usage: || This is a replacement line to multiple Cardioplegia Delivery Sets-and includes the female luer connector" that is the subject of this correction/removal activity
  • Manufacturer
  • 1 Event

Manufacturer

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