# FDA recall Z-2513-2023

> **Cook Vandergrift, Inc.** · Class II · device recall initiated 2023-07-24.

## 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

- **Recall number:** Z-2513-2023
- **Recalling firm:** Cook Vandergrift, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-07-24
- **Report date:** 2023-09-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Vandergrift, PA, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-2513-2023. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-2513-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*