Date Initiated by Firm |
May 24, 2006 |
Date Posted |
July 12, 2006 |
Recall Status1 |
Terminated 3 on July 11, 2006 |
Recall Number |
Z-1219-06 |
Recall Event ID |
35680 |
510(K)Number |
K042040
|
Product Classification |
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection - Product Code NFA
|
Product |
TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 190 cm (for embolism protection). The kit includes AutoStream Flow Control, Flush Kit, ShieldWire (temporary occlusion balloon guidewire), and Balloon Inflation Syringe). The system is used with a standard 7F guide catheter using the standard femoral approach. |
Code Information |
Lot number 47303 exp 9/30/06 |
Recalling Firm/ Manufacturer |
Kensey Nash Corp 735 Pennsylvania Dr Exton PA 19341-1130
|
For Additional Information Contact |
Robin Fatzinger, RAC 484-713-2100
|
Manufacturer Reason for Recall |
Volume control knob not able to go up to larger diameters
|
FDA Determined Cause 2 |
Other |
Action |
A letter was issued to the sales representative that have customers which received affected product, 5/24/2006. Sales representatives visited their sites within 3 days to determine if the affected product was still in inventory. If the product was still in inventory the sales representative provided the trained TriActiv System user(s) a Technical Bulletin that instructed the users how to correct the knob position. |
Quantity in Commerce |
10 kits |
Distribution |
Nationwide. The products are shipped to hospitals in AL, DE, Fl, IL, IN, MI, PA, SC, TN 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 = NFA and Original Applicant = KENSEY NASH CORP.
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