Device Recall Ultrasound Probe Cover

  • Model / Serial
    Product Code 9001C0197. Lot numbers 61177, 61189, 61211, 61219, 61250, 61280, 61293, 61304, 63141, 63147, 63200, 63210, 63235, 63269, 63304, 63324, 63357, 63372, 63375, 63398, 63409, 63421, 63442, 63450, 63458, 63494, 63505, 63533, 63558, 63559, 63584, 63590, 63616, 63634, 63685, 63723, 63750, 63782, 63798, 63824, 63846, 63895, 63913, 63933, 63952, 63981, 64006, 64024, 64028, 64029, 64053, 64079, 64094, 64109, 64126, 64137, 64147, 64148, 64163, 64183, 64205, 64206, 64220, 64228, 64236, 64257, 64290, 64305, 64317, 64318, 64329, 64351, 64352, 64376, 64377, 64400, 64434, 64459, 64512, 64540, 64586, 64606, 64645, 64646,.
  • 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 Ultrasound Probe Cover with Gel
  • 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
    Lot number: 0520, expiration date: 1-10.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed to one consignee: Cone Instruments, 5210 Naiman Parkway, Solon, OH 44139.
  • Product Description
    Ultrasound probe cover, sterile. Catalog No. 910811.
  • Manufacturer
  • Model / Serial
    Lot Numbers: D111571, D120421, D123471, D83111, DA90721, and DA90961
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, Malta, Norway, Poland, Portugal, and Canada.
  • Product Description
    Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96, REF VPC0699, STERILE EO, QTY 20, Manufactured for Vital Care Reps, Inc., Tinley Park, Illinois
  • Manufacturer