Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
FDA Recall #Z-0966-2019 — Class II — December 20, 2018
Product Description
Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
Reason for Recall
Presence of natural rubber latex is not declared in the label
Recalling Firm
Terumo Cardiovascular Systems Corporation — Elkton, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
12 packs
Distribution
TX
Code Information
Lot Numbers: V A30
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated