Medical device recalls Moderate risk

Bard Peripheral Vascular Inc recalls POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venou…

Recall date
February 8, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1772-2018
FDA classification
Class II
Brand / firm
Bard Peripheral Vascular Inc
Sold / distributed
Nationwide

Why it was recalled

The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.

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

What was recalled

POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00004

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