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U.S. Department of Health and Human Services

Class 2 Device Recall FX Spare Shieldwire Inflators

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  Class 2 Device Recall FX Spare Shieldwire Inflators 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-0834-2007
Recall Event ID 37701
510(K)Number K061772  
Product Classification Embolic Protection System - Product Code FRO
Product FX Spare Shieldwire Inflators (3.0 - 5.0 mm), Catalog number 60042-02. The product is sold 5 per box.
Code Information Catalog number 60042-02. Lot numbers 49320 exp 4/30/07, 51710 exp 7/31/07, 52340 exp 8/31/07, 52884 exp 9/30/07, 53210 exp 10/31/07, and 53614 exp 10/31/07
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 109 units
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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