| Date Initiated by Firm | October 17, 2006 |
|---|
| Date Posted | December 08, 2006 |
|---|
| Recall Status1 |
Terminated 3 on July 16, 2008 |
| Recall Number | Z-0207-2007 |
|---|
| Recall Event ID |
36622 |
| Product Classification |
Blood Glucose Test Strips - Product Code NBW
|
| Product | OneTouch/Basic/Profile Blood Glucose Test Strips, 50 Test Strips per box. Part Number 020-848, LIFESCAN, a Johnson & Johnson company. (The product is labeled in English, Greek and Portuguese) |
|---|
| Code Information |
Lots 2606340, 2619932, 272894A; Part # 020-848. |
| FEI Number |
3003666334
|
Recalling Firm/
Manufacturer |
Medishop USA
6 Bay St Fl 4th
Brooklyn NY 11231-1902
|
| For Additional Information Contact | Mr. Thomas Riquier
347-223-5922 |
|---|
Manufacturer Reason
for Recall | Counterfeit-(manufacturer unknown) |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | The recalling firm faxed, e-mailed and/or mailed ''Urgent Medical Device'' letters and response forms (dated 10/17/06) to the 5 distributor accounts. |
|---|
| Quantity in Commerce | 7,727 boxes (50 strips per box) |
|---|
| Distribution | Worldwide Distribution-including the states of NY, NJ, MS and country of Canada |
|---|
| 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.
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