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Class 2 Device Recall SureStep 50 Test Strips |
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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
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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
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For Additional Information Contact |
Customer Service Department 800-579-5280
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Manufacturer Reason for Recall |
Products labeled 'For Sale Outside The USA and Canada,' were being offered for sale in the U.S.
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FDA Determined Cause 2 |
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.
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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
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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.
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