Device Recall Terumo Custom Cardiovascular and Perfusion Procedure Kits

  • Model / Serial
    Catalog Number: 6XXXX Lot Numbers: ML07, MM18, MM25, MN08, MN IS, MN22.  Manufacturing dates September 7, 20 I 0 through November 22, 20 I 0.  Catalog Number: 7XXXX Lot Numbers: ML07,ML20, MM18, MM25, MNO1, MN08, MN15, MN29,MP06, MP13. Manufacturing dates September 7, 2010 through December 13,2010.
  • 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 Cardiovascular and Perfusion Procedure Kits || Catalog Codes: Kits with a 5-digit code beginning with the digit 6: || Catalog Number: 6XXXX ; || Catalog Codes: Kits with a 5-digit code beginning with the digit 7: Catalog Number: 7XXXX || Product usage: || The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it.
  • Manufacturer
  • 1 Event

Manufacturer

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