Devices

Device Recall Acclarent

  • Model / Serial
    Catalog #, Lot #, Manufacture Date, Expiration Date: BID30, 99456168, 09/2005, 09/2010, BID30,99455806, 08/2005, 08/2010, BID30, 99455018, 08/2005, 08/2010, BID30, 99458283, 09/2005, 09/2010, BID30, 99457941, 10/2005, 10/2010, BID30, 99464320, 12/2005, 10/2008, BID30,,99464317, 11/2005, 11/2010
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The product was released for distribution to 15 consignees in US. The recall was appropriately extended to the consumer/user level; i.e., the direct accounts (users) who received the recalled product. There is one Veterans Affairs account: Dept. of Veterans Affairs Medical Center PA, 1 215 823-4659, University & Woodland Avenues, Philadelphia, PA 19104, USA
  • Product Description
    Acclarent brand Relieva Sinus Inflation Device Kit; || Model BID30; The kit contains 1 inflation device, 1-10'' extension tube, 1-20cc syringe, 3-way stop-cock; Manufactured for Acclarent, Inc., 1525-B O''Brien Dr., Menlo Park, CA 94025
  • Manufacturer
    Acclarent Inc
  • 1 Event

Manufacturer

Acclarent Inc
  • Manufacturer Address
    Acclarent Inc, 1525-B O'Brien Drive, Menlo Park CA 94025
  • Source
    USFDA