Medical Vision Ab recalls Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid distension and irrigation and flui…

Recall date

May 10, 2016

Source

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

Recall number

Z-2705-2016

FDA classification

Class II

Brand / firm

Medical Vision Ab

Sold / distributed

Distributed to the US, to the states of NH, OK, AL, PA, IL, MA, TX, MI, NC, CA, MN, CT, GA, NY, WI, KY, OH, VA, AL, NJ, TN, SD, and IN.

Why it was recalled

Sterility of device may be compromised due to sterile package breakage.

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

What was recalled

Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid distension and irrigation and fluid suction during diagnostic and operative arthroscopic procedures.