FDA Device recall Z-2368-2020
Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing…
- FDA Device
- Class II
- terminated
- Published 2020-06-24
On 2020-06-24 the FDA classified a Class II recall of Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing… 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-2368-2020 |
| 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 GIC Port A Cath, Sterile, Qty 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 303394REG: lot numbers: 259427, 262441, 264440, 268589, 268915, 271008, and 269694. |
|---|
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-2368-2020%22
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