Cook Vandergrift, Inc. recalls Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. O…

Recall date

July 24, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2513-2023

FDA classification

Class II

Brand / firm

Cook Vandergrift, Inc.

Sold / distributed

Worldwide distribution - US Nationwide including PR and the countries of AE, AT, AU, BE, BN, BY, CA, CH, CL, CO, CZ, DE, DK, ES, FI, FR, GB, GT, HK, HU, IE, IL (EUDC), IL (NADC), IT, JP, KW, MX, NL, NO, PL, PR, PT, SE, TH, TR, UY, ZA.

Why it was recalled

Sterility of device may be compromised due to breach of the chevron seal of the packaging

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001