Events

Recall of Device Recall Atkinson Retrobulbar Anesthesia Needles

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

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
    38382
  • Event Risk Class
    Class 3
  • Event Number
    Z-1197-2007
  • Event Initiated Date
    2007-07-11
  • Event Date Posted
    2007-08-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-08-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53513
  • 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
    Anesthesia Needles - Product Code HMX
  • Reason
    Mislabeled: boxes actually contained tri-fact needles.
  • Action
    The recalling firm telephoned the hospital on 7/11/07 to inform them of the problem and the need to return the product. As a follow up to the telephone call, the recalling firm issued a recall letter via FedEx on 7/11/07. The firm's representative is making arrangements to pick up the recalled product.

Device

Device Recall Atkinson Retrobulbar Anesthesia Needles
  • Model / Serial
    Catalog number 8065420920, Lot number 700894M.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    CA.
  • Product Description
    Atkinson Retrobulbar Anesthesia Needles, 25 gauge 1 1/2". Catalog Number 8065420920. The product is sold in boxes that contain 10 needles each.
  • Manufacturer
    Alcon Research, Ltd

Manufacturer

Alcon Research, Ltd
  • Manufacturer Address
    Alcon Research, Ltd, 6201 South Fwy, Fort Worth TX 76134-2001
  • Source
    USFDA