Device recall
Z-1063-2020: Centurion-LVAD Kits DM1005 DAILY LVAD MAINTENANCE KIT DM280A LVAD MANAGEMENT…
FDA device recall · Class II · Centurion Medical Products Corporation
Key facts
| Recall number (Z-number) | Z-1063-2020 |
|---|---|
| Recall event | 84530 |
| Product | 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… |
| Product code | OXQ |
| Recalling firm | Centurion Medical Products Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 4, 2020 |
| FEI number | 3008403546 |
At a glance
- None Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database