FDA Device recall Z-0876-2022
Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT G34502
- FDA Device
- Class III
- terminated
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class III recall of Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT G34502 by Cook Medical, citing IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0876-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-02-14 |
| Published | 2022-04-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cook Medical |
| Distribution | US |
Product
Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT G34502; IGTCFS-65-1-JUG-CELECT-PT G34309; IGTCFS-65-1-UNI-CELECT-PT G34505;
Reason
IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
Identifiers
| code_info | All Lots manufactured within 24 Jan 2019 through 24 Jan 2022. Expiration range from January 8, 2022 through January 18…All Lots manufactured within 24 Jan 2019 through 24 Jan 2022. Expiration range from January 8, 2022 through January 18 2025. IGTCFS-65-1-UNI-CELECT-PT G34505 E3814946 (01)10827002345055(17)221501(10)E3814946 IGTCFS-65-1-UNI-CELECT-PT G34505 E3819087 (01)10827002345055(17)223001(10)E3819087 IGTCFS-65-1-UNI-CELECT-PT G34505 E3814444 1082700234505520220114E3814444 IGTCFS-65-1-UNI-CELECT-PT G34505 E3814546 1082700234505520220114E3814546 IGTCFS-65-1-UNI-CELECT-PT G34505 E3815516 1082700234505520220116E3815516 IGTCFS-65-1-UNI-CELECT-PT G34505 E3815843 1082700234505520220122E3815843 IGTCFS-65-1-UNI-CELECT-PT G34505 E3815844 1082700234505520220122E3815844 IGTCFS-65-1-UNI-CELECT-PT G34505 E3817094 1082700234505520220123E3817094 IGTCFS-65-1-UNI-CELECT-PT G34505 E3817095 1082700234505520220123E3817095 IGTCFS-65-1-UNI-CELECT-PT G34505 E3817236 1082700234505520220123E3817236 IGTCFS-65-1-UNI-CELECT-PT G34505 E3817237 1082700234505520220123E3817237 IGTCFS-65-1-UNI-CELECT-PT G34505 E3 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0876-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.