Events

Recall of Device Recall Acclarent

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Acclarent Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    34524
  • Event Risk Class
    Class 2
  • Event Number
    Z-0559-06
  • Event Initiated Date
    2006-01-20
  • Event Date Posted
    2006-02-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-05-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44014
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Instrument, Ent Manual Surgical - Product Code LRC
  • Reason
    Device sterility may be compromised as evidenced by a loss of package integrity.
  • Action
    On 1/20/06 the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned.

Device

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

Manufacturer

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