Events

Recall of Battery-operated Cautery || Low Temperature, fine/elongated Tip

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Aaron Medical Industries, 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
    29487
  • Event Risk Class
    Class 2
  • Event Number
    Z-1238-04
  • Event Initiated Date
    2004-06-29
  • Event Date Posted
    2004-08-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33829
  • 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
    Unit, Cautery, Thermal, Battery-Powered - Product Code HQP
  • Reason
    The cover caps on some of these cauteries are not properly engaged to prevent inadvertent activation.
  • Action
    Each consignee will be notified by letter of the recall with instruction for the disposal of the product determined to be hazardous. Each letter will have a questionnaire attached with a 800 fax number for replying to the firm.

Device

Battery-operated Cautery || Low Temperature, fine/elongated Tip
  • Model / Serial
    Sterile lot numbers: 0204B 0204D 0204E 0304A 0304C 0304D 0404A 0404E 0404G 0404H 0404J 0504A 0504C 0504E 0504F. EXP DATES 2/1/08-5/1/04
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to: 291 accounts in the USA, 8 in Canada, 18 in Europe, 1 in the Middle East, 1 in Asia, 4 in the Pacific Rim 1 in Africa and 5 US goverment/Military.
  • Product Description
    Battery-operated Cautery || Low Temperature, fine/elongated Tip
  • Manufacturer
    Aaron Medical Industries, Inc.

Manufacturer

Aaron Medical Industries, Inc.
  • Manufacturer Address
    Aaron Medical Industries, Inc., 7100 30th Ave N, St Petersburg FL 33710-2902
  • Source
    USFDA