Device evidence

device-recall:cfres:178610

Centurion-LVAD Kits DM1005 DAILY LVAD MAINTENANCE KIT DM280A LVAD MANAGEMENT SYSTEM 2-7 DM320 PERCUTANEOUS LEAD MANAGEMENT KIT DM380 DAILY LVAD KIT MORRISTOWN MEDICAL DM405A ADVOCATE CHRIST DAILY WET KIT DM405A ADVOCATE CHRIST DAILY WET KIT DM525 LVAD SENSITIVE KIT DM545 U OF U LVAD SENSITIVE SKIN DRESSING SYST DM550 VAD DRIVELINE MANAGEMENT TRAY DM555 LVAD MULTI-DAY DRIVELINE MGMT SIZE M/L DM565 LVAD DRESSING SYSTEM DM575 LVAD MULTI-DAY DRIVELINE MGMT SIZE S DM610 DRIVELINE MANAGEMENT SYSTEM-DAILY DM610 DRIVELINE MANAGEMENT SYSTEM-DAILY DM610 DRIVELINE MANAGEMENT SYSTEM-DAILY DM690 VAD DRIVELINE MANAGEMENT BUNDLE DM710 VAD DAILY DRESSING CHANGE KIT DM720 DAILY LVAD MAINTENANCE KIT DM765 DAILY DRIVELINE MANAGEMENT SYSTEM DM770 WEEKLY DRIVELINE MANAGEMENT SYSTEM DM775 EXTENDED WEAR DRIVELINE MANAGEMENT KIT DM775 EXTENDED WEAR DRIVELINE MANAGEMENT KIT DM805 DAILY LVAD DRIVELINE MANAGEMENT SYSTEM DM870 DAILY MAINTENANCE SYSTEM LVAD DM920 GAUZE DRIVELINE MANAGEMENT KIT DM925 SORBAVIEW DRIVELINE MANAGEMENT KIT DM935 DAILY DRIVELINE MANAGEMENT SYSTEM DM950 HIGH DRAINAGE LVAD TRAY

Official recall number

Z-1063-2020

Evidence summary

Product code: OXQ
Recall status: Terminated
Event initiated: December 11, 2019
Root cause: Packaging process control
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1063-2020