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U.S. Department of Health and Human Services

Class 2 Device Recall TriActiv FX Embolic Protection System 7F

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  Class 2 Device Recall TriActiv FX Embolic Protection System 7F see related information
Date Initiated by Firm March 28, 2007
Date Posted May 31, 2007
Recall Status1 Terminated 3 on August 30, 2007
Recall Number Z-0833-2007
Recall Event ID 37701
510(K)Number K061772  
Product Classification Embolic Protection System - Product Code FRO
Product TriActiv FX Embolic Protection System 7F, Catalog numbers 60040-02 (has 190 cm guidewire) and 60040-03 (has 300 cm guidewire). The devices are comprised of four principal components including the ShieldWire Balloon Guidewire, the Shieldwire Inflator, the FX or LFX Catheter, and the AutoStream Flow Control.
Code Information Catalog numbers 60040-02 and 60040-03. Lot numbers 49709 exp 3/31/07, 51844 exp 5/31/07, 52822 exp 7/31/07, 53209 exp 5/31/07, 53252 exp 7/31/07, 54264 exp 7/31/07, 54276 exp 11/30/07, 49912 exp 3/30/07, 50952 exp 5/31/07, 51714 exp 7/31/07, 52488 exp 5/31/07, and 54248 exp 11/30/07.
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		 Insufficient wire sealing
FDA Determined
Cause 2		 Other
Action On 3/26/07, the recalling firm left voice mail message with all sales representatives instructing the sales representatives to contact all TriActiv FX accounts immediately. Recall notices were faxed on 3/28/07 to all accounts which received the product. Recall notices instructed the hospitals to quarantine all FX and to contact their sales representative to arrange for retrieval of the product if they had not already been contacted.
Quantity in Commerce 427 kits
Distribution Worldwide, including USA and Germany.
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 = FRO and Original Applicant = KENSEY NASH CORP.
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