Device Recall Sterile needle guide kit

  • Model / Serial
    Product Code 9001C0214. Lot numbers: 61187, 61233, 61258, 61302, 61332, 63189, 63220, 63245, 63270, 63339, 63360, 63398, 63401, 63402, 63422, 63451, 63515, 63521, 63538, 63564, 63612, 63615, 63666, 63729, 63766, 63783, 63830, 63862, 63925, 63957, 63973, 64042, 64094, 64108, 64148, 64182, 64218, 64229, 64258, 64261, 64268, 64378, 64419, 64420, 64440, 64460, 64493.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    Site-Rite Sterile Needle Guide Kit - 20 gauge
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Bard Access Systems, Inc, 5425 Amelia Earhart Dr, Salt Lake City UT 84116-3713
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    Product Code 9001C0212. Lot numbers: 61208, 61233, 61258, 61287, 61308, 63189, 63220, 63225, 63263, 63305, 63338, 63360, 63383, 63402, 63414, 63442, 63472, 63515, 63530, 63564, 63597, 63646, 63720, 63766, 63783, 63817, 63845, 63875, 63924, 63953, 63991, 64056, 64063, 64125, 64164, 64191, 64258, 64261, 64269, 64330, 64364, 64401, 64420, 64433, 64448, 64452, 64514, 64652.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    Site-Rite Sterile Needle Guide Kit - 18 gauge
  • Manufacturer
  • Model / Serial
    Product Code 90013B01. Lot Numbers 61189, 61219, 61280, 61302, 61332, 63141, 63147, 63171, 63245, 63262, 63339, 63360, 63401, 63421, 63422, 63450, 63451, 63521, 63538, 63590, 63615, 63666, 63723, 63729, 63770, 63814, 63830, 63862, 63913, 63925, 63991, 63998, 64028, 64063, 64080, 64137, 64151, 64192, 64218, 64229, 64261, 64289, 64330, 64353, 64375, 64401, 64447, 64492, 64550, 64591.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    Site-Rite Sterile Needle Guide Kit - 21 Gauge
  • Manufacturer