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Class 3 Device Recall OneTouch Ultra Test Strips |
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| Date Initiated by Firm |
October 19, 2005 |
| Date Posted |
December 08, 2005 |
| Recall Status1 |
Terminated 3 on July 05, 2006 |
| Recall Number |
Z-0273-06 |
| Recall Event ID |
33943 |
| 510(K)Number |
k043197
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| Product Classification |
System, Test, Blood Glucose, Over The Counter - Product Code NBW
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| Product |
LifeScan brand OneTouch Ultra Test strips, 25 strips per vial |
| Code Information |
Lot number 2591755, part number 020-245-07 |
Recalling Firm/
Manufacturer |
Lifescan Inc
1000 Gibraltar Dr
Milpitas CA 95035-6301
|
Manufacturer Reason
for Recall |
Vials of OneTouch Ultra Test Strips marked with quantities of 25 per vial actually contain only 10 strips.
|
FDA Determined
Cause 2 |
Other |
| Action |
The firm has issued a letter to distributors, along with a Pass-along letter for notifying sub-distribution consignees, as well as letters for end users and a notification letter on its website. |
| Quantity in Commerce |
5799 vials |
| Distribution |
Product was distributed to 9 consignees in NY, KY, MO, AL, TN, LA and IL. |
| Total Product Life Cycle |
TPLC Device Report
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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.
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| 510(K) Database |
510(K)s with Product Code = NBW and Original Applicant = LIFESCAN, INC.
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