Cook Incorporated recalls Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneou

Recalled April 24, 2024 · FDA recall Z-1531-2024 · Cook Incorporated

Hazard

Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility · FDA Class II

Units

1,493 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

Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER (RPN)/ORDER NUMBER (GPN): 1) JCD10.0-38-20-HC G10207 2) JCD14.0-38-20-HC G10293 3) JCD16.0-38-20-HC G10206 4) JCD6.0-38-20-HC G10285 5) JCD8.0-38-20-HC G10289

Manufacturer(s)

Cook Incorporated

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →