Firefly Medical, Inc. recalls IVEA 500A Intended for Med-Surg patient care.

Recall date

November 1, 2016

Source

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

Recall number

Z-0767-2017

FDA classification

Class II

Brand / firm

Firefly Medical, Inc.

Sold / distributed

Worldwide Distribution -- USA and Canada.

Why it was recalled

The dowel pin could potentially slip out of its press fit, resulting in the product potentially slumping to one side which could cause the patient to stumble.

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

What was recalled

IVEA 500A Intended for Med-Surg patient care.