Device Recall Haemonetics

  • Model / Serial
    Serial Numbers: 06F018, 06E133, 06A294-2, 06E132, 06A289 Foreign: 06C251, 06C252, 06C253, 06C254, 06C255, 06C242, 05D074-1, 06D075-1, 06F014-1, 06C248
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AZ, CT, GA, NE, MS Austria, France, Taiwan
  • Product Description
    SmartSuction Harmony Powered Suction Device || Model Number: HAR-E-115-US
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Haemonetics Corporation, 400 Wood Rd, Eastern Maine Medical Center, Braintree MA 02184-2412
  • Source
    USFDA

4 devices with a similar name

Learn more about the data here

  • Model / Serial
    All lot numbers
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, MN, NE, TX
  • Product Description
    cardioPAT Cardiovascular Perioperative Autotransfusion System, Model: LN 2050-110-E || and Disposables: || cardioPAT Replacement RBC Bags, LN 00270 || cardioPAT Replacement Waste Bags, LN 00271 || cardioPAT Replacement Intraoperative Suction Set, LN 00272 || cardioPAT Replacement Postoperative Suction Set, LN 00273 || cardioPAT cardiovascular Perioperative Autotransfusion System Disposable Set, LN 00274 || cardioPAT Replacement One-Way Valve Assembly LN 00275
  • Manufacturer
  • 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
  • Model / Serial
    All serial numbers
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution, including USA, Australia, Belgium, Canada, Switzerland, China, Germany, Finland, France, United Kingdom, Hong Kong, Israel, Italy, Japan, Netherlands, Russian Federation, and Sweden.
  • Product Description
    Haemonetics cardioPAT Cardiovascular - autotransfusion System || Catalog Number: 02050-US
  • Manufacturer
  • Model / Serial
    All serial numbers
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and countries including: Australia, Austria, AEU, Belgium, Bangladesh, Canada, China, France, Germany, Hong Kong, India, Indonesia, Italy, Japan, Korea, Malaysia, Mexico, New Zealand, Pakistan, Philippines, Singapore, Sri Lanka, Taiwan and Turkey.
  • Product Description
    2380 MINI Hand-Held Tube Sealer Power Source || (including a 23802000 Battery Pack) || The Model 2380 Power Source is an instrument that generates RF power for making seals on tubing made of RF reactive thermoplastic materials typically used in blood banks, blood processing facilities and transfusion centers.
  • Manufacturer