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 |
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
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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
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