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;
Reported: April 13, 2022 Initiated: February 14, 2022 #Z-0876-2022
Product Description
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
Details
- Recalling Firm
- Cook Medical Incorporated
- Units Affected
- 52,590 units
- Distribution
- US Nationwide - Worldwide Distribution Foreign: Canada, Bahamas ,Chile Guam
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
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;. Recalled by Cook Medical Incorporated. Units affected: 52,590 units.
Why was this product recalled? ▼
IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 13, 2022. Severity: Low. Recall number: Z-0876-2022.
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