Food, drugs, devices › Resource Optimization & Innovation LLC
Device recall: Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Flush Syringes are intended to be used onl
FDA enforcement event 85632 is a device recall by Resource Optimization & Innovation LLC of Saint Louis, MO, initiated 4 May 2020 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 23 Sep 2022. Initiation: voluntary: firm initiated. Resource Optimization & Innovation LLC has 9 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Resource Optimization & Innovation LLC, Saint Louis, MO.
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."
Distribution
"US Nationwide distribution including in the states of MO, NC."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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 of indwelling of vascular access devices. | 9,360 units | Class II | Terminated | 24 Jun 2020 |
| 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 indwelling of vascular access devices. | 12,640 units | Class II | Terminated | 24 Jun 2020 |
Context
Other enforcement events for Resource Optimization & Innovation LLC
All 9 events for Resource Optimization & Innovation LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution including in the states of MO, NC."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 23 Sep 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.