Class Il Kensey Nash Corp

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 a software problem has caused false positive 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.

CODE
Lot number 48275, exp. 1/07

RECALLING FIRM/MANUFACTURER
Kensey Nash Corp., Exton, PA, by letter on April 17, 2006. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
69 kits

DISTRIBUTION
Germany and Italy

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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