FDA Device recall Z-2265-2020
Regard
- FDA Device
- Class II
- terminated
- Published 2020-06-17
On 2020-06-17 the FDA classified a Class II recall of Regard by Roi Cps, citing custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2265-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-20 |
| Published | 2020-06-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Roi Cps |
| Distribution | US |
Product
Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.
Reason
Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.
Identifiers
| code_info | Lot no. 68336DRW. Item number: 830034. UDI: (01) 10326053106634 (17) 210131 (10) 68336DRW. |
|---|
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-2265-2020%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.