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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 October 13, 2006
Date Posted December 16, 2006
Recall Status1 Terminated 3 on July 24, 2007
Recall Number Z-0262-2007
Recall Event ID 36656
Product Classification Blood Glucose Test Strips - Product Code CGA
Product One Touch Ultra Blood Glucose Test Strips
Code Information Lot Number: 2691191
Recalling Firm/
Manufacturer		 Medical Plastics Devices Inc
161 Oneida drive
Point Claire, Quebec Canada 05478
For Additional Information Contact Malcolm Bullock, CFO
514-694-9835 Ext. 273
Manufacturer Reason
for Recall		 Counterfeit Glucose Test Strips (manufacturer unknown)
FDA Determined
Cause 2		 Other
Action Medical Plastic Devices, Quebec, Canada notiifed customers by telephone on 10/17/06 and completed notification by letter on 10/18/06.
Quantity in Commerce 3,353 boxes (both Recall Z-0261 and Z-0262-2007)
Distribution Nationwide
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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