Device Recall Modified MP4Cardioplegia Delivery System with Conducer

  • Model / Serial
    Item Number: 58520-Lot Numbers: MF24, MM11, MN01. Manufacturing dates May 24, 20 I 0 through November I, 2010  Item Number: 1610-Lot Numbers: MM11, MN08, MNI5, MN29 MP07. Manufacturing dates October 11, 20 I 0 through December 7, 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 Set - Heat Exchanger Cardiopulmonary Bypass || Item Numbers: 5852, 16010 || Product Usage: || This is a Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4:1 ratio. In includes a Conducer Heat Exchanger and a Bubble Trap module. Additionally, the set is constructed with a female luer connector that is the subject of the 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