Device Recall Haemonetics cardioPAT Cardiovascular Perioperative Autotransfusion System

  • Model / Serial
    All serial numbers
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) and the countries of Canada, France, Germany, Great Britain, Italy, Japan, Spain, and The Netherlands.
  • Product Description
    Haemonetics cardioPAT -Cardiovascular Perioperative Autotransfusion System || Model 2050 US || Models Out-Side the US: || 02050-UK, 02050-ES, 02050-IT, 02050-NL, 02050-GE, 02050-FR, 02050-JA || The Haemonetics¿ Cardiovascular Perioperative Autotransfusion System || for Use (cardioPAT) is indicated for use to salvage red blood cells from blood lost intraoperatively and postoperatively during cardiovascular surgical || procedures, where the expected rate of processing of salvaged blood and fluid || aspirated from the surgical site is less than or equal to two liters per hour.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Haemonetics Corporation, 400 Wood Rd, Braintree MA 02184-2412
  • Manufacturer Parent Company (2017)
  • Source
    USFDA