Medical device recalls Moderate risk

Cordis Corporation recalls Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S

Recall date
January 8, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1477-2020
FDA classification
Class II
Brand / firm
Cordis Corporation
Sold / distributed
US and UK

Why it was recalled

Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area.

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 POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S

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