Devices

Device Recall CombiSet True Flow Series

  • Model / Serial
    Lot Numbers:  8ER273, 8HR038, 8JR021, 8KR013, 8LR013, 8ER283, 8HR066, 8JR075, 8KR032, 8LR020, 8HR114, 8JR136, 8KR060, 8LR048, 8HR125, 8JR142, 8KR113, 8LR074, 8HR189, 8JR167, 8KR131, 8LR123, 8HR207, 8JR193, 8KR159, 8LR209, 8HR225, 8JR209, 8KR170, 8LR909, 8HR241, 8JR222, 8KR200, 8HR266, 8JR266, 8KR210, 8HR285, 8KR228, 8KR250, and 8KR271.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and country of Canada.
  • Product Description
    CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) || Product Code: 03-2794-0 || Bonded CombiSets - includes priming set w/ needleless access port & Y-injection site bonded to arterial line, viral-retentive transducers and Twister device
  • Manufacturer
    Fresenius Medical Care North America
  • 1 Event

Manufacturer

Fresenius Medical Care North America
  • Manufacturer Address
    Fresenius Medical Care North America, 920 Winter St, Waltham MA 02451-1521
  • Manufacturer Parent Company (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall CombiSet True Flow Series
  • Model / Serial
    Lot number 8LR902 only
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and country of Canada.
  • Product Description
    CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) || Product Code: 03-2994-6 24 sets / case || CombiSet Bloodlines Including split-septum injection site, viral-retentive transducer protectors, & priming set & Twister device
  • Manufacturer
    Fresenius Medical Care North America