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U.S. Department of Health and Human Services

Class 2 Device Recall TriActiv System Procedure Kit 340 cm

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 Class 2 Device Recall TriActiv System Procedure Kit 340 cmsee related information
Date Initiated by FirmMay 24, 2006
Date PostedJuly 12, 2006
Recall Status1 Terminated 3 on July 11, 2006
Recall NumberZ-1220-06
Recall Event ID 35680
510(K)NumberK042040 
Product Classification Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection - Product Code NFA
ProductTriActiv System Procedure Kit. Balloon Protected Flush Extraction System 340 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 femoral approach.
Code Information Lot number 47303 exp 9/30/06
FEI Number 1000307073
Recalling Firm/
Manufacturer		 Kensey Nash Corp
735 Pennsylvania Dr
Exton PA 19341-1130
For Additional Information ContactRobin 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
ActionA 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 Commerce10 kits
DistributionNationwide. The products are shipped to hospitals in AL, DE, Fl, IL, IN, MI, PA, SC, TN and TX.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NFA
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