Device Recall LifeShield Hema Gemstar YType Blood Pump Set

  • Model / Serial
    Lot numbers: 540755H, 551055H and 591145H.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- U.S., Puerto Rico, Dominican Republic, Bahamas, Virgin Islands, Argentina, Australia, Bahrain, Belgium, Canada, China, Denmark, Ecuador, EI Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Italy, Jordan, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay, and United Arab Emirates.
  • Product Description
    Lifeshield, latex-free, HEMA, GEMSTAR, Y-Type Blood Pump Set, nonvented, 110 inch with CLAVE and OPTION-LOK, 10 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 13244-01.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Hospira Inc., 375 N Field Dr, Lake Forest IL 60045-2513
  • Manufacturer Parent Company (2017)
  • Source
    USFDA