Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is i...
FDA Recall #Z-1330-2025 — Class II — February 7, 2025
Product Description
Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
Reason for Recall
Catheter manufactured at the incorrect length.
Recalling Firm
Cordis US Corp — Miami Lakes, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
12 units
Distribution
US: WA OUS: Japan
Code Information
UDI: 20705032042991/ Lot Number: 18368326
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated