Class 2 Device Recall SureStep 50 Test Strips

• Date Initiated by Firm: October 08, 2002
• Date Posted: December 31, 2002
• Recall Status: Terminated 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/ Manufacturer: River City Drug; 1800 Sandy Plains Pkwy; Bldg 100 Suite 112; Marietta GA 30066
• For Additional Information Contact: Customer Service Department; 800-579-5280
• 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: Other
• 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.