RegWardenFDA facility compliance records
Recall

Class II — Resource Optimization & Innovation LLC

Recalling firmResource Optimization & Innovation
Registered facilityResource Optimization & Innovation, LLC (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonA kit component, the PDI Prevantics Swab, was recalled.
ProductRegard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
Quantity3,570 kits
DistributionUS distribution to two consignees located in Missouri
Initiated2022-02-28
Classified2022-04-18
Terminated2022-05-24
Recall numberZ-0950-2022
InitiationVoluntary: 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-0950-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89793/

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