| Date Initiated by Firm | May 23, 2003 |
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| Date Posted | February 27, 2004 |
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| Recall Status1 |
Terminated 3 on May 07, 2004 |
| Recall Number | Z-0554-04 |
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| Recall Event ID |
26463 |
| 510(K)Number | K001563 |
|---|
| Product Classification |
Dislodger, Stone, Flexible - Product Code FGO
|
| Product | SCIPRO Flexible Stone Dislodger and Retrieval Set Catalog # SP3000146ST |
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| Code Information |
Lot # OML30403-01 |
| FEI Number |
1000113395
|
Recalling Firm/
Manufacturer |
Scion Cardio-Vascular, Inc.
14256 SW 119 Avenue
Miami FL 33186
|
| For Additional Information Contact | Ramon Augusto Paz
305-259-8880 Ext. 107 |
|---|
Manufacturer Reason
for Recall | Possible difficulty for the user in opening the stone retrieval basket. |
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FDA Determined
Cause 2 | Other |
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| Action | The firm mailed a recall letter on May 23, 2003 with a pre-paid FedEx shipment label to the consignees requesting that they return the indicated product and lot number. The firm recieved a response from each consignee and accounted for all shipped product by 6/24/2003. |
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| Quantity in Commerce | 28 |
|---|
| Distribution | Product was distributed 12 hospitals and clinics in NJ, RI, NY, PA, VA, KY, TX, OH, TX AND FL. |
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| 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 = FGO
|
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