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U.S. Department of Health and Human Services

Class 1 Device Recall One Touch Ultra

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  Class 1 Device Recall One Touch Ultra see related information
Date Initiated by Firm November 01, 2006
Date Posted December 29, 2006
Recall Status1 Terminated 3 on September 25, 2012
Recall Number Z-0264-2007
Recall Event ID 36696
Product Classification Blood Glucose Test Strips - Product Code NBW
Product OneTouch Ultra- Blood Glucose test strips. For use with One Touch Brand Meters blood glucose meters
Code Information Lot # 2691191 and 2691261
Recalling Firm/
Manufacturer
Royal Global Wholesale
5681 Northpointe Lane
Boynton Beach FL 33437
Manufacturer Reason
for Recall
Counterfeit Glucose Test Strips
FDA Determined
Cause 2
Other
Action The firm notified its consignees by phone and issued a recall letter on 11/3/2006. Consumers who have the product were advised to destroy the product or return it to the retail outlet where it was purchased.
Quantity in Commerce 10,116
Distribution Worldwide
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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