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

Recalled September 13, 2023 · FDA recall Z-2513-2023 · Cook Vandergrift

Hazard

Sterility of device may be compromised due to breach of the chevron seal of the packaging · FDA Class II

Units

15,951

Sold at

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.

Description

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

Product

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

Manufacturer(s)

Cook Vandergrift, Inc.

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