Device Recall Site Rite Systems containing needle guide kits.

  • Modèle / numéro de série
    Site Rite II System - Item Numbers: 9740001-9740006. Serial number ranges: 32563-32624, 33450-33549, 35900-35999, 37300-37399, 37950-38028.  Site Rite 3 System - Item Numbers: 9740010-9740019. Serial number ranges: 32774-32974, 34900-35149, 36100-36199, 36450-36510, A02001-A02383.  Site Rite IV System - Item Numbers: 9740050-9740052, 9740059, 9740091, 9760004, 9760018. Serial number ranges: B03001-B03588, B03590-B03601, B03603-B03607, B03609, B03632, B03636, B03647.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide. Foreign distribution to: Austria; Bahrain, Belgium, Bermuda, Brazil, Canada, Greece, Hong Kong, Italy, Japan, Kuwait, Malaysia, Mexico, Norway, Oman, Pakistan, Portugal, Qatar, Saudi Arabia, Switzerland, Turkey, United Arab Emirates, United Kingdom.
  • Description du dispositif
    Site Rite II, Site Rite 3, and Site Rite IV Systems with 2 Sterile Kits each.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Bard Access Systems, Inc, 5425 Amelia Earhart Dr, Salt Lake City UT 84116-3713
  • Source
    USFDA