FDA recall Z-2168-2019

Centurion Medical Products Corporation · Class II · device

Product

HIGH DRAINAGE LVAD TRAY Kit Code: DM950 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line 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-2168-2019