Date Initiated by Firm | February 21, 2003 |
Date Posted | March 20, 2003 |
Recall Status1 |
Terminated 3 on April 21, 2003 |
Recall Number | Z-0663-03 |
Recall Event ID |
25680 |
Product Classification |
Catheter, Intravascular, Diagnostic - Product Code DQO
|
Product | Stretta brand Catheter and Accessory Kit, Part # 175-2575. Model 4301K |
Code Information |
FD1268 thru FD1282 |
Recalling Firm/ Manufacturer |
Curon Medical Inc 735 Palomar Avenue Sunnyvale CA 94086
|
For Additional Information Contact | Vivian Filimon 408-616-1841 |
Manufacturer Reason for Recall | Catheter shaft has potential to crack during use. |
FDA Determined Cause 2 | Other |
Action | On 2/21/03 the firm initiated the recall and its notification was via letters to inform its consignees about the problem with its catheters. It requests immediate discontinuance of all product with certain lot numbers. |
Distribution | Product was released for distribution to 52 direct accounts nationwide including 1 VA Medical Center, Endoscopy Dept., 150 S. Huntington Ave., Boston, MA 02130, ATTN: Dr. Hiroshi Mashimo, ph#: 617-363-5640. |
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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