| Date Initiated by Firm | June 26, 2007 |
|---|
| Date Posted | August 22, 2007 |
|---|
| Recall Status1 |
Terminated 3 on November 27, 2007 |
| Recall Number | Z-1191-2007 |
|---|
| Recall Event ID |
38351 |
| 510(K)Number | K924163 |
|---|
| Product Classification |
Diagnostic Cardiac Catheter - Product Code DRF
|
| Product | Polaris Dx Diagnostic Catheter, for cardiac electrophysiology studies, Model M0049663S0 |
|---|
| Code Information |
Batch numbers 9535942, 9596195, 9618290. Catalog Model number/Product UPN number M00496630 |
| FEI Number |
3001236349
|
Recalling Firm/
Manufacturer |
Boston Scientific Corp
2710 Orchard Pkwy
San Jose
CA
95134
|
| For Additional Information Contact |
508-652-5594 |
|---|
Manufacturer Reason
for Recall | Product is mislabeled as hexapolar (6 electrodes), but is actually quadripolar (4 electrodes). |
|---|
FDA Determined
Cause 2 | Labeling mix-ups |
|---|
| Action | The firm issued notification letters to its consignees, sent 06/26/2007, via FedEx. The firm intends to remove the product and destroy it. |
|---|
| Quantity in Commerce | 30 units |
|---|
| Distribution | Product was distributed to 3 consignees in Florida and Tennessee. |
|---|
| 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 = DRF
|
|---|
