Class 1 Device Recall One Touch Basic/Profile

• Date Initiated by Firm: October 13, 2006
• Date Posted: December 16, 2006
• Recall Status: Terminated on July 24, 2007
• Recall Number: Z-0261-2007
• Recall Event ID: 36656
• Product Classification: Blood Glucose Test Strips - Product Code NBW
• Product: One Touch Basic/Profile Blood Glucose test strips
• Code Information: Lot Numbers: 2619932, 2606340
• 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: 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.