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Medtronic recalls Best Practices kits containing certain production lots of Clearify Visualization System Item Code: 21-345 Intended to
Recalled December 28, 2016 · FDA recall Z-0890-2017 · Medtronic
Hazard
Product sterility is compromised due to breach of the sterile barrier · FDA Class II
Units
230 systems
Sold at
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 Serbia Slovakia South Africa Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom
Description
Product sterility is compromised due to breach of the sterile barrier
Product
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
Manufacturer(s)
Medtronic
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →