Events

Recall of Device Recall Beekley Medical SPOTS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Beekley 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
    62526
  • Event Risk Class
    Class 2
  • Event Number
    Z-2110-2012
  • Event Initiated Date
    2012-07-09
  • Event Date Posted
    2012-07-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110838
  • 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
    System, x-ray, film marking, radiographic - Product Code JAC
  • Reason
    Digital skin mammography marker separating from the backing of the spot material.
  • Action
    Beekley Medical issued an Urgent Medical Device Recall letter dated July 9, 2012 to all affected customers. The letter identified the affected products, problem and actions to be taken. Customers were advised to contact Beekley Medical's Customer Service Team at 1-800-233-5539 to return affected lots for replacement. Customers were instructed to complete and return the attached reply form.

Device

Device Recall Beekley Medical SPOTS
  • Model / Serial
    Lot Numbers:  A015, A016, AO17, A018
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Beekley A-Spots Floral Skin Markers -Order Number: 751 || Product Usage: || Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern
  • Manufacturer
    Beekley Corporation

Manufacturer

Beekley Corporation
  • Manufacturer Address
    Beekley Corporation, 1 Prestige Ln, Bristol CT 06010-7468
  • Manufacturer Parent Company (2017)
    Beekley Corporation
  • Source
    USFDA