PlainRecalls
FDA Devices Moderate Class II Terminated

HIGH DRAINAGE LVAD TRAY Kit Code: DM950 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.

Reported: August 14, 2019 Initiated: July 1, 2019 #Z-2168-2019

Product Description

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

Details

Units Affected
192 each
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.
Location
Williamston, MI

Frequently Asked Questions

What product was recalled?
HIGH DRAINAGE LVAD TRAY Kit Code: DM950 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.. Recalled by Centurion Medical Products Corporation. Units affected: 192 each.
Why was this product recalled?
Potential for sterile packaging to be compromised
Which agency issued this recall?
This recall was issued by the FDA Devices on August 14, 2019. Severity: Moderate. Recall number: Z-2168-2019.