Events

Recall of Sterile Aquasonic 100 Ultrasound Transmission Gel

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Parker Laboratories, 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
    79910
  • Event Risk Class
    Class 2
  • Event Number
    Z-1777-2018
  • Event Initiated Date
    2017-04-13
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163914
  • 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, imaging, pulsed echo, ultrasonic - Product Code IYO
  • Reason
    There is a potential for the gel packets to have leaks in the packet seal.
  • Action
    Notification letters distributed 4/13/17 instructed customers to perform the following: We request that you quarantine any affected product in your inventory and contact Parker to discuss options for disposition of the recalled products in question. Should you identify any customers to whom the affected product may have already been distributed, we would be happy to provide you with a customer letter that can be transcribed onto your own company letterhead for the purposes of notifying them of this quality issue. Please completed the attached response form as soon as possible and return it to us at the email or fax number listed on the form, so that further arrangements can be made.

Device

Sterile Aquasonic 100 Ultrasound Transmission Gel
  • Model / Serial
    Lot numbers: L0117006, L0117007, L0217001, L0217002, L0217004, L0217006
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were distributed to the following US states: CA, FL, GA, IA, IL, OH, TN, and VA. The products were distributed to the following foreign countries: Canada, United Kingdom, and Malta.
  • Product Description
    Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
  • Manufacturer
    Parker Laboratories, Inc.

Manufacturer

Parker Laboratories, Inc.
  • Manufacturer Address
    Parker Laboratories, Inc., 286 Eldridge Rd, Fairfield NJ 07004-2509
  • Manufacturer Parent Company (2017)
    Parker Laboratories Inc
  • Source
    USFDA