Medtronic recalls Best Practices kits containing certain production lots of Clearify Visualization System Item Code: 21-345 Intended to b…

Recall date

October 4, 2016

Source

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

Recall number

Z-0890-2017

FDA classification

Class II

Brand / firm

Medtronic

Sold / distributed

Worldwide Distribution - US (Nationwide) Foreign: Austria Belgium Bulgaria Brazil Chile Cyprus Denmark Egypt Finland France France Germany Greece Hungary Iran Ireland Israel Italy Japan Kenya Kuwait Latvia Luxembourg Mexico Namibia Netherlands Nigeria Norway Poland Portugal Romania Saudi Arabia Ser…

Why it was recalled

Product sterility is compromised due to breach of the sterile barrier

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

What was recalled

Best Practices kits containing certain production lots of Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens