Class 1 Device Recall One Touch

• Date Initiated by Firm: October 14, 2006
• Date Posted: January 05, 2007
• Recall Status: Terminated on June 06, 2007
• Recall Number: Z-0266-2007
• Recall Event ID: 36863
• Product Classification: Blood Glucose Test Strips - Product Code NBW
• Product: One Touch Basic/Profile and One Touch Ultra Blood Glucose Test Strips
• Code Information: One Touch Basic/Profile Lot #''s 2606340, 2619932, 272894A, 2615211 One Touch Ultra Lot #''s 2691191, 2691261
• Recalling Firm/ Manufacturer: Core Care Technologies, Inc; 309 Fries Mill Rd., Suite 14; Sewell NJ 08080
• For Additional Information Contact: Ronald Manno; 856-218-2476
• Manufacturer Reason for Recall: Counterfeit product (manufacturer unknown)
• FDA Determined Cause: Other
• Action: The firm identified the customers who had been sent OneTouch test strips since August 2006 and contacted each by phone to identify the lot number of the test strips in the customer's possession. A letter was sent on 11/21/2006 by first class mail which identified the lot numbers identified in the letter from the law firm and providing instructions to follow if the affected lots were found.
• Quantity in Commerce: unknown
• 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.