Vascular Solutions, Inc. recalls Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 15cm Product The Draine…

Recall date

May 4, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2249-2018

FDA classification

Class II

Brand / firm

Vascular Solutions, Inc.

Sold / distributed

US Nationwide Distribution

Why it was recalled

The supplier of Drainer(R) centesis catheters notified Vascular Solutions, Inc. that there is a potential for certain production lots to contain unsafe levels of bacterial endotoxins.

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

What was recalled

Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 15cm Product The Drainer centesis catheter is intended for use in percutaneous fluid aspirations and small volume drainage procedures.