| Date Initiated by Firm | July 01, 2004 |
| Date Posted | January 05, 2005 |
| Recall Status1 |
Terminated 3 on February 12, 2008 |
| Recall Number | Z-0380-05 |
| Recall Event ID |
29817 |
| 510(K)Number | K896025 K926499 |
| Product Classification |
Vehicle, Motorized 3-Wheeled - Product Code INI
|
| Product | Victory Motorized Vehicle, 3 wheel Model SC1600 |
| Code Information |
Model SC1600 |
Recalling Firm/ Manufacturer |
Pride Mobility Product Corp 182 Susquehanna Avenue Exeter PA 18643
|
| For Additional Information Contact | Michael Zablocky 570-655-5574 Ext. 1410 |
Manufacturer Reason for Recall | intermittent operation |
FDA Determined Cause 2 | Other |
| Action | The recalling firm issued a safety alert notification to all dealers/distributors dated 7/04. |
| Quantity in Commerce | 17000 units |
| Distribution | The product was shipped to medical supply stores nationwide. There are five foreign accounts in Australia, Canada Great Britain, Italy, and Netherlands. There are twelve government accounts. |
| 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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| 510(K) Database | 510(K)s with Product Code = INI
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