Recall Z-2166-2019— Centurion Medical Products Corporation

Name: FDA recall Z-2166-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-01

Class II · Terminated

Class II FDA medical device recall by Centurion Medical Products Corporation, initiated 2019-07-01, terminated 2020-06-26. FDA's recall record names no specific 510(k) clearance for this event. Product: LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used for Left Ventricular Assist Device Dressing System for general patient population.. Reason: Potential for sterile packaging to be compromised.

Recalling firm: Centurion Medical Products Corporation
Classification: Class II
Status: Terminated
Initiated: 2019-07-01
Terminated: 2020-06-26
Firm location: Williamston, MI, United States

Product description

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

Reason for recall

Potential for sterile packaging to be compromised

Data sourced from openFDA. This site is unofficial and independent of the FDA.