| Date Initiated by Firm | May 21, 2007 |
|---|
| Date Posted | July 23, 2007 |
|---|
| Recall Status1 |
Terminated 3 on August 29, 2007 |
| Recall Number | Z-1115-2007 |
|---|
| Recall Event ID |
38055 |
| 510(K)Number | K060016 |
|---|
| Product Classification |
Thrombectomy Catheter - Product Code MCW
|
| Product | ThromCat Thrombectomy Catheter System. Catalog number 63000-01 |
|---|
| Code Information |
Catalog number 63000-01, Lot number 57292 exp March 2008 |
| FEI Number |
1000307073
|
Recalling Firm/
Manufacturer |
Kensey Nash Corp
735 Pennsylvania Dr
Exton PA 19341-1130
|
| For Additional Information Contact | Robin M. Fatzinger
484-713-2100 Ext. 2146 |
|---|
Manufacturer Reason
for Recall | Defective component (power supply) |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | New power supplies were sent directly to Sales Representatives who personally replaced the defective power supplies and returned them to Kensey Nash. A voice mail to all affected KNC Sales Representatives went out on 5/21/07 instructing them to contact the affected accounts immediately. |
|---|
| Quantity in Commerce | 11 units |
|---|
| Distribution | Nationwide:The products were shipped to medical facilities in FL, MO, NJ, and TX. |
|---|
| 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 = MCW
|
|---|
