Events

Recall of Device Recall Deionized water

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Wescor, 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
    54187
  • Event Risk Class
    Class 3
  • Event Number
    Z-1029-2010
  • Event Initiated Date
    2010-01-06
  • Event Date Posted
    2010-03-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-04-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87789
  • 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
    Eosin Y - Product Code HYB
  • Reason
    Stains used for diagnostic use may be contaminated with bacteria.
  • Action
    Customers were notified by letter on Jan. 6, 2010 and asked to destroy any remaining product. A response form was included to note whether or not customer had any remaining stock for replacement purposes. Additional information is available at 800-453-2725 or regaff@wescor.com.

Device

Device Recall Deionized water
  • Model / Serial
    Lot numbers: 102443, 103233 and 103941.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, Foreign distribution to Algeria, Australia, Austria, Canada, Cyprus, Denmark, France, Germany, Hungary, Ireland, Italy, Japan, Kuwait, Malta, Netherlands, Oman, Panama, Poland, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, United Arab Emirates, UK, and Venezuela.
  • Product Description
    SS-H2O Aerospray Deionized Water, 500 mL, IVD, Wescor, Inc, Logan, Utah 84321.
  • Manufacturer
    Wescor, Inc

Manufacturer

Wescor, Inc
  • Manufacturer Address
    Wescor, Inc, 1700 S 370 W, Logan UT 84321
  • Source
    USFDA