Events

Recall of Parker

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
    69224
  • Event Risk Class
    Class 2
  • Event Number
    Z-0145-2015
  • Event Initiated Date
    2014-08-06
  • Event Date Posted
    2014-10-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129977
  • 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
    Parker laboratories, inc. received a report of an incorrect expiration date on the inner boxes and on the plastic bags of the eclipse probe covers.
  • Action
    Parker Laboratories Inc. sent an "Urgent Medical Device Product Recall" Letter/Response Form via Fedex to their customers. The letter indentified the affected product, problem and actions to be taken. For questions contact Parker Laboratories Quality Assurance at 973-276-9500, ext. 7142.

Device

Parker
  • Model / Serial
    Lot #D424, Part Number PM-038-0224E and BA-046-3801D 4/27/10
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) and country of: Canada.
  • Product Description
    Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, Size: 2.37/1.75"W x 9.5"L (60/44 mm x 241 mm), Lot #D424, Expiry date 04/2016, Pre-gelled inside with Aquasonic 100 Ultrasound Transmission Gel || Product Usage: For use as a protective cover for medical ultrasound probes/transducers.
  • Manufacturer
    Parker Laboratories, Inc.

Manufacturer

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