Medical device recalls Moderate risk

ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit recalled over foreign material

Recall date
January 2, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Arrow International Inc recalls ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the ce…
Recall number
Z-1082-2015
FDA classification
Class II
Brand / firm
Arrow International Inc
Sold / distributed
Nationwide

Why it was recalled

Foreign material found within the kits. The foreign material, white or black particles and/or thread, is visible and can beidentified by the user.

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

What was recalled

ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins.

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