Events

Recall of Hologic

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hologic, 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
    75558
  • Event Risk Class
    Class 2
  • Event Number
    Z-0655-2017
  • Event Initiated Date
    2016-10-28
  • Event Date Posted
    2016-11-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150787
  • 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
    Sound, uterine - Product Code HHM
  • Reason
    Breach in sterile barrier compromising product sterility.
  • Action
    Hologic notified customers in the United States through Certified letter on 10/28/16. The letter contains instructions with the option of returning or destroying the product, provides contact information, and includes a postage paid return card for the consignee to complete and return to Hologic.Questions or require clarification of the response process please contact 1- 800-442-9892 and selection option 6 and then option 2 for surgical product technical support. For questions regarding this recall call 508-263-8920.

Device

Hologic
  • Model / Serial
    Lot Code US: 16E25RC 16E25RD 16F16R  Lot Code OUS: 16E25RB
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) and Internationally to Finland and Austria.
  • Product Description
    SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. || SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. || For uterine sound
  • Manufacturer
    Hologic, Inc

Manufacturer

Hologic, Inc
  • Manufacturer Address
    Hologic, Inc, 250 Campus Dr, Marlborough MA 01752-3020
  • Manufacturer Parent Company (2017)
    Hologic Inc
  • Source
    USFDA