FDA Device recall Z-2166-2019
LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used for Left Ventricular Assist Device Dressing System for general…
- FDA Device
- Class II
- terminated
- Published 2019-08-14
On 2019-08-14 the FDA classified a Class II recall of LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used for Left Ventricular Assist Device Dressing System for general… by Centurion Medical Products, citing potential for sterile packaging to be compromised.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2166-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-01 |
| Published | 2019-08-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Centurion Medical Products |
| Distribution | US |
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
Potential for sterile packaging to be compromised
Identifiers
| code_info | Lot # 2019031190 Exp: 06/30/2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2166-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.