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
|