Date Initiated by Firm |
January 07, 2010 |
Date Posted |
October 01, 2010 |
Recall Status1 |
Terminated 3 on March 14, 2011 |
Recall Number |
Z-2639-2010 |
Recall Event ID |
54382 |
510(K)Number |
K062195
|
Product Classification |
System, Test, Blood Glucose, Over The Counter - Product Code NBW
|
Product |
One Touch Ultra Test Strips, Part Number 020-245-32, lot number 2964512, Manufactured by LifeScan Inc., Milpitas, CA. |
Code Information |
Part Number 020-245-32, lot number 2964512, manufactured between 09/10/2009 and 09/24/2009, distributed between 09/30/2009 and 10/27/2009. |
Recalling Firm/ Manufacturer |
Lifescan Inc 1000 Gibraltar Dr Milpitas CA 95035
|
For Additional Information Contact |
408-942-5903
|
Manufacturer Reason for Recall |
One Touch Ultra Test Strip products may actually contain a different product, One Touch Select strips.
|
FDA Determined Cause 2 |
Mixed-up of materials/components |
Action |
Notification was issued by the firm during the first week of February. This letter asked consignees to share the information with patients, and are asking users to contact the firm and to examine their stock for the recalled product. |
Quantity in Commerce |
9631 cartons, 4 vials per carton |
Distribution |
Product was distributed to one wholesale dealer and one distributor and 2 medical facilities in CA, OH and PA, as well as the UK. |
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.
|