Medical device recalls Moderate risk

Centurion Medical Products Corporation recalls LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used for Left Ventricular Assist Device Dressing…

Recall date
July 1, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2166-2019
FDA classification
Class II
Brand / firm
Centurion Medical Products Corporation
Sold / distributed
US Nationwide distribution in the states of AZ, CA, FL, GA, IL, KY, MA, MD, MI, NC, NH, NY, OH, SC, TX, TN, VA, WA, WI.

Why it was recalled

Potential for sterile packaging to be compromised

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

What was recalled

LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used for Left Ventricular Assist Device Dressing System for general patient population.

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