Medical device recalls Moderate risk

Cordis US Corp recalls Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only

Recall date
March 4, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1510-2025
FDA classification
Class II
Brand / firm
Cordis US Corp
Sold / distributed
US Distribution to states of: AR, AZ, FL, NJ, TN; and OUS Foreign country of: Japan

Why it was recalled

product mix-up; Vascular stent labeled as one size but contains a different size.

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

What was recalled

Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only

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