Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for nonvascular use. REFERENCE PART NUMBER (RPN)/ ORDER NUMBER (GPN): 1)PLVW-7.0-35 G00925 2)PLVW-8.0-35 G01844 : DTVN-5.0-19-10.0- YUEH : G09490

Reason: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

Code information: UDI-DI/Lot Number: 1) (01)00827002009257(17) 15777767 2) (01)00827002018440(17) NS15787532

Distribution pattern: Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.