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U.S. Department of Health and Human Services

Class 2 Device Recall SureStep 50 Test Strips

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  Class 2 Device Recall SureStep 50 Test Strips see related information
Date Initiated by Firm October 08, 2002
Date Posted December 31, 2002
Recall Status1 Terminated 3 on September 07, 2005
Recall Number Z-0398-03
Recall Event ID 25193
Product Classification Colorimeter, Photometer, Spectrophotometer For Clinical Use - Product Code JJQ
Product 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.
Code Information Lot: E-169380A, Exp: 2003-01.
Recalling Firm/
River City Drug
1800 Sandy Plains Pkwy
Bldg 100 Suite 112
Marietta GA 30066
For Additional Information Contact Customer Service Department
Manufacturer Reason
for Recall
Products labeled 'For Sale Outside The USA and Canada,' were being offered for sale in the U.S.
FDA Determined
Cause 2
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.
Quantity in Commerce 576 units
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.