Food, drugs, devices › Resource Optimization & Innovation LLC
Device recall: Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
FDA enforcement event 89793 is a device recall by Resource Optimization & Innovation LLC of Saint Louis, MO, initiated 28 Feb 2022 and classified Class II, with 1 product record.
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. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 24 May 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
"A kit component, the PDI Prevantics Swab, was recalled."
Distribution
"US distribution to two consignees located in Missouri"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0950-2022 | Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site | 3,570 kits | Class II | Terminated | 27 Apr 2022 |
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: "A kit component, the PDI Prevantics Swab, was recalled."
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 distribution to two consignees located in Missouri"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 24 May 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.