Events

Recall of Device Recall Micron Bobbin Vent Tube

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

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
    54356
  • Event Risk Class
    Class 1
  • Event Number
    Z-0797-2010
  • Event Initiated Date
    2010-01-08
  • Event Date Posted
    2010-03-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88309
  • 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
    Tympanostomy Tube - Product Code ETD
  • Reason
    Units of the product in lot mh136952 may have been shipped without being sterilized.
  • Action
    The firm initiated their recall on 01/04/2010 by telephone or visit to their consignees. A follow-up Urgent: Medical Device Recall correspondence, dated 1/14/2010, was sent on 01/27/2010, return receipt requested, to both the consignees and the implanting surgeons. The follow-up letter identified the affected product and described the issue. Customers are to immediately cease any further use of any affected product and quarantine it. Also, they are to obtain a Return Goods Authorization and return the affected product to the firm. The reply form should be completed and also returned. Questions should be directed to customer service at 1-800-773-4301.

Device

Device Recall Micron Bobbin Vent Tube
  • Model / Serial
    Lot Number: MH136952.
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- Including states of FL, GA, OH, TX, RI, IL, MI, and KS.
  • Product Description
    MICRON¿ ¿ BOBBIN VENT TUBE, 1.27 MM I.D., TITANIUM, REF 145281-ENT, QTY 1, STERILE EO, GYRUS ACMI INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01772 USA. || Intended to be implanted for ventilation or drainage of the middle ear.
  • Manufacturer
    Gyrus ACMI Corporation

Manufacturer

Gyrus ACMI Corporation
  • Manufacturer Address
    Gyrus ACMI Corporation, 136 Turnpike Rd, Southborough MA 01772-2118
  • Source
    USFDA