FDA recall Z-2166-2019

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 for recall

Potential for sterile packaging to be compromised

Distribution

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.

Key facts

Status

Terminated

Initiation date

2019-07-01

Report date

2019-08-14

Termination date

2020-06-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Williamston, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2166-2019