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U.S. Department of Health and Human Services

Class 2 Device Recall TriActiv ProGuard Embolic Protection System

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  Class 2 Device Recall TriActiv ProGuard Embolic Protection System see related information
Date Initiated by Firm April 06, 2006
Date Posted July 28, 2006
Recall Status1 Terminated 3 on August 10, 2006
Recall Number Z-1305-06
Recall Event ID 35280
Product Classification Embolic Protection System - Product Code NFA
Product TriActiv ProGuard Embolic Protection System, Part number 61000-01. The product is shipped as a procedure kit. It is used with a standard 6F guide catheter using the standard femoral approach.
Code Information Part number 61000-01. Lot number 48275 exp 1/07
Recalling Firm/
Kensey Nash Corp
735 Pennsylvania Dr
Exton PA 19341-1130
For Additional Information Contact Robin Fatzinger
Manufacturer Reason
for Recall
Alarm activiation-A priming issue involving the flow control unit due to a software problem has caused false postive Extraction Line Block (ELB) alarming. Use of this product may result in a health hazard resulting from early termination of the flush and extraction procedure after stenting
FDA Determined
Cause 2
Action The recalling firm issued a draft recall letter to their European distributor who translated the letter for their customers.
Quantity in Commerce 69 kits
Distribution The product was shipped to hospitals in Germany and Italy.
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.