Events

Recall of SureStep 50 Test Strips

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by River City Drug.

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
    25193
  • Event Risk Class
    Class 2
  • Event Number
    Z-0398-03
  • Event Initiated Date
    2002-10-08
  • Event Date Posted
    2002-12-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-09-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25358
  • 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
    Colorimeter, Photometer, Spectrophotometer For Clinical Use - Product Code JJQ
  • Reason
    Products labeled 'for sale outside the usa and canada,' were being offered for sale in the u.S.
  • Action
    Letters were sent via regular mail to customers on/about 10/08/02 with a response card attached. Customers were informed of the recall, and were urged to contact their accounts and to return their outstanding recall stock to River City Drug for full credit.

Device

SureStep 50 Test Strips
  • Model / Serial
    Lot: E-169380A, Exp: 2003-01.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide. AZ, CA, DE, FL, GA, KY, KS, HI, IA, IL, LA, MA, MD, MI, MN, MO, NC, NM, NV, OH, OK, PA, SC, SD, TN, TX, VA, WA, WI, WV. There are no foreign or government accounts involved.
  • Product Description
    SureStep 50 Test Strips, For the measurement of glucose in whole blood, Two bottles of 25 Test Srips, LIFESCAN, a Johnson & Johnson Company, Milpitas, CA 95035, USA, Lot: E-169380A, Exp: 2003-01.
  • Manufacturer
    River City Drug

Manufacturer

River City Drug
  • Manufacturer Address
    River City Drug, 1800 Sandy Plains Pkwy, Bldg 100 Suite 112, Marietta GA 30066
  • Source
    USFDA