Company: Kensey Nash Corp., Date of Enforcement Report:8/9/2006 Class:ll 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, Recall # Z-1305-06 REASON Alarm activation-A priming issue involving the flow control unit due to...Read More
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