# FDA recall Z-0876-2022

> **Cook Medical Incorporated** · Class III · device recall initiated 2022-02-14.

## 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 for recall

IFU update includes an update to the Device  description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions,  Potential adverse events

## Distribution

US Nationwide - Worldwide  Distribution  Foreign: Canada, Bahamas ,Chile Guam

## Key facts

- **Recall number:** Z-0876-2022
- **Recalling firm:** Cook Medical Incorporated
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-02-14
- **Report date:** 2022-04-13
- **Termination date:** 2024-11-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomington, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0876-2022

## Citation

> AI Analytics. FDA recall Z-0876-2022. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0876-2022. Source: US FDA. Licensed CC0.

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