Events

Recall of Device Recall 0SPOT Mammography Skin Markers (REF 652)

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
    77295
  • Event Risk Class
    Class 3
  • Event Number
    Z-2309-2017
  • Event Initiated Date
    2017-05-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155635
  • 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
    Mammography skin marker 0 -spot (ref 652) product was mis-labeled with a-spot (ref 651) labels.
  • Action
    Beekley Medical issued letter dated May 8, 2017 advised user of the problem and to examine inventory and return product.C Accounts requested to complete response form . Questions: Quality Assurance & Regulatory Manager at 1-800-233-5539 x 434.

Device

Device Recall 0SPOT Mammography Skin Markers (REF 652)
  • Model / Serial
    LOT 652.04251701
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : AR, CA GA, IL, TX, MN, NV, NY, WI., and Internationally to Canada.
  • Product Description
    Beekley Medical 0-SPOT Mammography Skin Markers || REF 652
  • 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