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Class 2 Device Recall Boston Scientific /Microvasive |
 |
| Date Initiated by Firm |
April 29, 2003 |
| Date Posted |
May 15, 2003 |
| Recall Status1 |
Terminated 3 on March 11, 2004 |
| Recall Number |
Z-0831-03 |
| Recall Event ID |
26206 |
| Product Classification |
Catheter, Angioplasty, Peripheral, Transluminal - Product Code LIT
|
| Product |
MaxForce TTS High Performance Esophageal Balloon Dilatation Catheter 14mm/42 Fr |
| Code Information |
Catalog Number: 8914 Lot Number: 5465675 |
Recalling Firm/
Manufacturer |
Boston Scientific Corporation
1 Boston Scientific Place
Natick MA 01760
|
| For Additional Information Contact |
Robert T. Miragliulo
508-652-5186
|
Manufacturer Reason
for Recall |
Catheter may be mislabeled
|
FDA Determined
Cause 2 |
Other |
| Action |
The firm notified each direct account by letter on 4/29/03 and, via letters of July 3 and July 11, 2003, extended the recall to three additional sizes of the catheter . Users were requested to check inventory, return the products to Boston Scientific and to reply regarding receipt of recall notification and the return of products.
|
| Quantity in Commerce |
9 units |
| Distribution |
CA, CO, IL, FL, HI, KY, LA, MA, ME, MI, NC, OH, PA, SC, TN, UT, VA, WA, WV, |
| 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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