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Cook Incorporated recalls Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end ca
Recalled April 24, 2024 · FDA recall Z-1528-2024 · Cook Incorporated
Hazard
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility · FDA Class II
Units
55 units
Sold at
Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
Description
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Product
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
Manufacturer(s)
Cook Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →