Class II — Resource Optimization & Innovation LLC
| Recalling firm | Resource Optimization & Innovation |
|---|---|
| Registered facility | Resource Optimization & Innovation, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field. |
| 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. |
| Quantity | 9,360 units |
| Distribution | US Nationwide distribution including in the states of MO, NC. |
| Initiated | 2020-05-04 |
| Classified | 2020-06-15 |
| Terminated | 2022-09-23 |
| Recall number | Z-2368-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Resource Optimization & Innovation LLC (Z-2368-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85632/
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