Medical device recalls Moderate risk

Terumo Cardiovascular Systems Corporation recalls Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222

Recall date
December 20, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0966-2019
FDA classification
Class II
Brand / firm
Terumo Cardiovascular Systems Corporation
Sold / distributed
TX

Why it was recalled

Presence of natural rubber latex is not declared in the label

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222

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