Cook Incorporated recalls Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for v

Recalled April 24, 2024 · FDA recall Z-1530-2024 · Cook Incorporated

Hazard

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

Units

5,998 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 - 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. 1) JCD10.0-38-20 2) JCD20.0-38-20 3) JCD22.0-38-20 4) JCD6.0-38-15 5) JCD8.0-38-15 6) JCD8.0-38-20

Manufacturer(s)

Cook Incorporated

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