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
