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U.S. Department of Health and Human Services

Class 3 Device Recall OneTouch Ultra

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  Class 3 Device Recall OneTouch Ultra see related information
Date Initiated by Firm October 10, 2005
Date Posted December 08, 2005
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = LIFESCAN, INC.
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