Class 3 Device Recall OneTouch Ultra

• Date Initiated by Firm: October 10, 2005
• Date Posted: December 08, 2005
• Recall Status: Terminated on November 21, 2006
• Recall Number: Z-0272-06
• Recall Event ID: 33942
• 510(K)Number: K043197
• Product Classification: System, Test, Blood Glucose, Over The Counter - Product Code NBW
• Product: LifeScan OneTouch Ultra Primary Care Physician Demo Kits, Blood Glucose Meter
• Code Information: Listing Number B026094, Code 90273 Kaban, all demo kits shipped between 04/08/2005 and 08/23/2005
• Recalling Firm/ Manufacturer: Lifescan Inc; 1000 Gibraltar Dr; Milpitas CA 95035-6301
• For Additional Information Contact: Healthcare Professional Line; 800-840-1756
• Manufacturer Reason for Recall: Users may inadvertently change units of measurement on demonstration kits of the OneTouch Ultra Blood Glucose Meters
• FDA Determined Cause: Other
• Action: A notification letter dated October 10, 2005 was issued to all health care professionals that requested the demo kit.
• Quantity in Commerce: 2843 kits
• Distribution: Distributed to 2843 total consignees, 2568 HCPs and 275 sales representatives throughout the USA, no foreign distribution
• 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.

• 510(K) Database: 510(K)s with Product Code = NBW