FDA Device recall Z-2513-2023
Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads
- FDA Device
- Class II
- ongoing
- Published 2023-09-13
On 2023-09-13 the FDA classified a Class II recall of Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads by Cook Vandergrift, citing sterility of device may be compromised due to breach of the chevron seal of the packaging.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2513-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-24 |
| Published | 2023-09-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cook Vandergrift |
| Distribution | US |
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
Sterility of device may be compromised due to breach of the chevron seal of the packaging
Identifiers
| code_info | Device Identifier (DI): (01)00827002200036(17) Lot Numbers: N172707 N172737 N172738 N172875 N172887 N172912 N173153 N17…Device Identifier (DI): (01)00827002200036(17) Lot Numbers: N172707 N172737 N172738 N172875 N172887 N172912 N173153 N173178 N173180 N173434 N173519 N173623 N173653 N173688 N173690 N173691 N173879 N173943 N173959 N173976 N173977 N174034 N174104 N174134 N174169 N174170 N174287 N174294 N174466 N174535 N174536 N174564 N174589 N174704 N174778 N174841 N174863 N174864 N174889 N174906 N175146 N175201 N175247 N175277 N175589 N175627 N175963 N175964 N175987 N176084 N176262 N176322 N176323 N176712 N176714 N176715 N176716 N176829 N176830 N176974 N177094 N177101 N177102 N177217 N177218 N177239 N177351 N177496 N177515 N177678 N177682 N177797 N177853 N177898 N177927 N178015 N178054 N178093 N178224 N178225 N178276 N178340 N178518 N178562 N178609 N178633 N178675 N178676 N178677 N178764 N178784 N178813 N178814 N179019 N179021 N179130 N179209 N179211 N179301 N179302 N179333 N179361 N179396 N179397 N179503 N179504 N179534 N179728 N179874 N179903 N180036 N180038 N180077 N180115 N180116 N180147 N180313 N180 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2513-2023%22
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