FDA recall Z-2513-2023

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

Reason for recall

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

Distribution

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.

Key facts

Status

Ongoing

Initiation date

2023-07-24

Report date

2023-09-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Vandergrift, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2513-2023