Device Recall Volcano R100 Sterile Equipment Cover

  • Model / Serial
    REF numbers: PBKGB and PBKBG-10 (10 pack): all lots
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed US (nationwide) and the countries of Australia, South Africa, Canada, New Zealand, Belgium, Japan, and Paraguay.
  • Product Description
    Volcano R100 Sterile Equipment Cover; Sterile; || General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile items may come into contact with them.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Volcano Corporation, 2870 Kilgore Rd, Rancho Cordova CA 95670-6133
  • Manufacturer Parent Company (2017)
  • Source
    USFDA