Medical device recalls Moderate risk

Bard Peripheral Vascular Inc recalls POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301

Recall date
February 8, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1763-2018
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 Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301

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