Cook Incorporated recalls Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0

Recalled April 24, 2024 · FDA recall Z-1525-2024 · Cook Incorporated

Hazard

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

Units

6,178 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

Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0 G01559 2) DCHN-18-10.0-U G05040 3) DCHN-18-15.0 G00850 4) DCHN-22-10.0 G00852 5) DCHN-22-10.0-U G03978 6) DCHN-22-15.0 G00012 7) DCHN-22-15.0-U G03314 8) DCHN-22-20.0 G00013 9) DCHN-22-20.0-U G04338

Manufacturer(s)

Cook Incorporated

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