Medical device recalls Moderate risk

Bard Peripheral Vascular Inc recalls PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter

Recall date
February 14, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0582-2020
FDA classification
Class II
Brand / firm
Bard Peripheral Vascular Inc
Sold / distributed
US - Nationwide OUS - None

Why it was recalled

Complaints received that products packaged with the incorrect introducer sheath 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

PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter

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