Cook Incorporated recalls Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for va

Recalled April 24, 2024 · FDA recall Z-1532-2024 · Cook Incorporated

Hazard

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

Units

4,856 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 - Coons Taper - 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- COONS G03928 2) JCD12.0-38-20- COONS G03929 3) JCD14.0-38-20- COONS G03932 4) JCD16.0-38-20- COONS G03947 5) JCD18.0-38-20- COONS G04051 6) JCD20.0-38-20- COONS G04264 7) JCD22.0-38-20- COONS G04443 8) JCD6.0-38-20- COONS G04221 9) JCD8.0-38-20- COONS G03927

Manufacturer(s)

Cook Incorporated

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