Date Initiated by Firm |
February 07, 2007 |
Date Posted |
March 08, 2007 |
Recall Status1 |
Terminated 3 on June 12, 2007 |
Recall Number |
Z-0597-2007 |
Recall Event ID |
37393 |
510(K)Number |
K060016
|
Product Classification |
Thrombectomy Catheter - Product Code MCW
|
Product |
ThromCat Thrombectomy Catheter System. 7F 2.5 -7.0 mm 150 cm. Catalogue number 63000-01. It is a single-use, disposable device that is used to perform percutaneous maceration and removal of thrombus and restoration of blood flow. |
Code Information |
Lot number 54877 exp December 2007, Lot number 55318 exp January 2008, Lot number 55218 exp January 2008, and Lot number 54821 exp December 2007 |
Recalling Firm/ Manufacturer |
Kensey Nash Corp 735 Pennsylvania Dr Exton PA 19341-1130
|
For Additional Information Contact |
Robin M. Fatzinger 484-713-2100
|
Manufacturer Reason for Recall |
Face seal may wear excessively and cause particulate matter.
|
FDA Determined Cause 2 |
Other |
Action |
On 2/7/07, a voice mail message was sent to all KNC Sales Representatives instructing them to contact affected accounts immediately. On 2/9/07, recall notices were faxed to all affected accounts that had affected product. The recall notices instructed hospitals to quarantine the affected lots and to contact their KNC Sales Representative to arrange for retrieval of the product. |
Quantity in Commerce |
165 units |
Distribution |
Nationwide. |
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 and Original Applicant = KENSEY NASH CORP.
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