Class II — Cook Vandergrift, Inc.
| Recalling firm | COOK VANDERGRIFT INC. |
|---|---|
| Registered facility | COOK VANDERGRIFT INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 |
| Quantity | 15,951 |
| 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. |
| Initiated | 2023-07-24 |
| Classified | 2023-09-01 |
| Recall number | Z-2513-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cook Vandergrift, Inc. (Z-2513-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92791/
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