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U.S. Department of Health and Human Services

Class 2 Device Recall TrActive System Balloon Inflation Syringe

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  Class 2 Device Recall TrActive System Balloon Inflation Syringe see related information
Date Initiated by Firm May 24, 2006
Date Posted July 12, 2006
Recall Status1 Terminated 3 on July 11, 2006
Recall Number Z-1221-06
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 Balloon Inflation Syringe. The syringe packs/boxes contain 5 'spare' syringes.
Code Information Lot numbers: 47052 exp 11/30/06, 47645 exp 12/31/06, and 49128 exp 3/31/07
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 15 boxes
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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