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U.S. Department of Health and Human Services

Class 1 Device Recall ONE TOUCH

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  Class 1 Device Recall ONE TOUCH see related information
Date Initiated by Firm October 17, 2006
Date Posted December 08, 2006
Recall Status1 Terminated 3 on July 16, 2008
Recall Number Z-0207-2007
Recall Event ID 36622
Product Classification Blood Glucose Test Strips - Product Code NBW
Product OneTouch¿/Basic¿/Profile¿ Blood Glucose Test Strips, 50 Test Strips per box. Part Number 020-848, LIFESCAN, a Johnson & Johnson company. (The product is labeled in English, Greek and Portuguese)
Code Information Lots 2606340, 2619932, 272894A; Part # 020-848.
Recalling Firm/
Manufacturer
Medishop USA
6 Bay St Fl 4th
Brooklyn NY 11231-1902
For Additional Information Contact Mr. Thomas Riquier
347-223-5922
Manufacturer Reason
for Recall
Counterfeit-(manufacturer unknown)
FDA Determined
Cause 2
Other
Action The recalling firm faxed, e-mailed and/or mailed ''Urgent Medical Device'' letters and response forms (dated 10/17/06) to the 5 distributor accounts.
Quantity in Commerce 7,727 boxes (50 strips per box)
Distribution Worldwide Distribution-including the states of NY, NJ, MS and country of Canada
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.
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