FDA Device recall Z-2369-2020
Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of…
- FDA Device
- Class II
- terminated
- Published 2020-06-24
On 2020-06-24 the FDA classified a Class II recall of Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of… by Resource Optimization And Innovation, citing there is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2369-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-05-04 |
| Published | 2020-06-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Resource Optimization And Innovation |
| Distribution | US |
Product
Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.
Reason
There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
Identifiers
| code_info | Item number 303399REG: lot numbers: 257967, 259035, 260742, 259418, 261252, 261888, 263836, 264669, 268918, 271005, 265730, 270198, and 270567. |
|---|
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-2369-2020%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.