Regard SRHS GIC Port A Cath — Class II medical device recall Z-2368-2020
Terminated recall by Resource Optimization & Innovation LLC, reported 2020-06-24, distributed nationwide. There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and po
| Recall number | Z-2368-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Resource Optimization & Innovation LLC, Saint Louis, MO, United States |
| Recall initiated | 2020-05-04 |
| Classified | 2020-06-15 |
| Reported by FDA | 2020-06-24 |
| Terminated | 2022-09-23 |
| Distributed | Nationwide (US) |
| Quantity | 9,360 units |
| Reason classes | sterility, packaging |
| Lot numbers | 259427, 262441, 264440, 268589, 268915, 269694, 271008 |
| Model numbers | 303394REG |
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 for recall
There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2368-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.