Medical device recalls Moderate risk

Terumo Cardiovascular Systems Corp recalls Cardiovascular Procedure Kit catalog # 76645 & 73806

Recall date
February 3, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0949-2022
FDA classification
Class II
Brand / firm
Terumo Cardiovascular Systems Corp
Sold / distributed
US Nationwide distribution in the states of CA and IN.

Why it was recalled

Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.

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 catalog # 76645 & 73806

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